11 08 11 Newsletter

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

1-888-749-2153 | www.ryortho.com

20 Zimmer’s 3rd Quarter - Steady Growth, Waiting for Patients................................................

Orthofix Beats Market and Expectations in 3Q11......................................................................NuVasive 3Q11: Noisy and Upward......................................................................Wright Medical 3Q: Ailing, Taking Medicine.....................................................................Smith & Nephew Revenue Grows 10% in 3Q11......................................................................New Options for Damaged Ankles......................................................................Whistleblower Costs DFine $2.39 Million for Kickbacks......................................................................Spineology Launches Own Fusion Device......................................................................JBJS: Timing of Lumbar Surgery

For all news that is ortho, read on.

week in review

breaking news

4 The Top Ten Best New Spine Technologies for 2011 ◆ Despite ever growing

hurdles to innovation and entrepreneu-rism in spine, ten solid new technolo-gies earned the top award for innova-tion and clinical effectiveness for 2011. This year, diagnostics and biologics were the most innovative and popular categories. And the winners are…

9 Spine Fusion Reimburse-ment: Science or Politics? ◆ A recent study reviewed medi-

cal payer policies for fusion. The study found discrepancies in the evidence used to develop the policies and, gen-erally lacked transparency. Some payer policies are based on guidelines that are not even publicly available for review. Read what the spine experts told OTW about the study.

13 Orthopaedic Crossfire® Tackles Metal on Metal ◆ A Current Concepts in

Joint Replacement™ debate between Joshua J. Jacobs, M.D. and Thomas P. Schmalzried, M.D. Hear what each party has to say about metal on metal.

17 Reporter’s Notebook ◆ “Committee of 12” with a bull’s-eye on healthcare?

New hires at K2M…out of the way, FDA…What Peter Indelicato, presi-dent of AOSSM, is excited about, and oh…hear what happens when some Viscogliosis go hunting. (Hint: no one was shot in a small bone.)



Orthopedic Power RankingsRobin Young’s Entirely Subjective Ordering of Public Orthopedic Companies

1 2 Zimmer 27.75% -1.42%ZMH adding $550 milion to war chest. Time to

buy growth? We think so. Also the least expensive company in ortho.

2 4 Medtronic 28.63 6.57InFuse attacked from the podium at NASS, but got

plenty of support from rank and file surgeons on the floor. Up one spot.

3 1 Stryker 25.23 1.95Buyers bidding SYK up which puts the company in the middle of the pack in terms of value. Down a

couple of spots.

4 8 Orthofix 14.72 1.64Great earnings report last week. Profits up a very

impressive 33%. Buyers will take notice, for sure. Big jump for OFIX.

5 3 Kensey Nash 34.24 0.6618% sales growth in September quarter led by strong

orthopedic sales. But valuation now down to 10th most attractive in ortho.

6 5Johnson &

Johnson26.33 2.84

6.8% sales growth in Q3 but a 6% profit decline due to higher overhead. Saving grace, that high dividend

and the coming Synthes purchase.

7 7 Conmed 9.65 10.83Flat sales but earnings beat Wall Street’s consensus. More products being made in Mexico—means more

profit gains in future quarters.

8 6Smith & Nephew

22.8 1.1Reported only 3% orthopedic sales growth in Q3 and profits were a disappointing 15.6%. Down a couple

spots this week.

9 NR Exactech 7.69 5.7834% jump in extremity sales plus 19% rise in hip

sales and 7% increase in knee sales puts EXAC back on the rankings.

10 9 Integra 15.38 -15.37IART hit a serious air pocket last week. Investors

worried about weak gross profit margin and lower operating profits as well.

Rank Last Company TTM Op 30-Day Comment Week Margin Price Change

This Week: Is this market melting up or down? We think that demand for all equities—orthopedics included—is likely heading south for the winter. The earliest that buyers emerge with any conviction, we think, will be on election year eve, just before the New Hampshire primaries in January.



Click Here for more detailsor email [email protected] Bishow: 410.356.2455 (office)or 410.608.1697 (cell)

Advertise with Orthopedics This Week

Robin Young’s Orthopedic Universe

Company Symbol Price Mkt Cap 30-Day Chg Company Symbol Price Mkt Cap 30-Day Chg

Company Symbol Price Mkt Cap P/E Company Symbol Price Mkt Cap P/E

Company Symbol Price Mkt Cap PEG Company Symbol Price Mkt Cap PEG

Top Performers Last 30 Days

Lowest Price / Earnings Ratio (TTM)

Lowest P/E to Growth Ratio (Earnings Estimates)

Worst Performers Last 30 Days

Highest Price / Earnings Ratio (TTM)

Highest P/E to Growth Ratio (Earnings Estimates)

Company Symbol Price Mkt Cap PSR Company Symbol Price Mkt Cap PSR

Lowest Price to Sales Ratio (TTM) Highest Price to Sales Ratio (TTM)

1 Bacterin Intl Holdings BONE $2.88 $114 44.72%2 RTI Biologics Inc RTIX $4.51 $249 31.49%3 TiGenix TIG.BR $1.10 $101 21.92%4 Conmed CNMD $26.41 $737 10.83%5 CryoLife CRY $4.69 $132 7.32%6 MAKO Surgical MAKO $37.44 $1,552 7.19%7 Synthes SYST.VX $168.12 $19,969 6.72%8 Medtronic MDT $34.38 $36,305 6.57%9 Exactech EXAC $15.55 $204 5.78%

10 Johnson & Johnson JNJ $64.12 175,712 2.84%

1 TranS1 TSON $1.66 $47 -45.93%2 Integra LifeSciences IART $29.56 $793 -15.37%3 Wright Medical WMGI $15.27 $601 -13.39%4 NuVasive NUVA $15.19 $642 -10.96%5 Alphatec Holdings ATEC $2.05 $183 -8.07%6 Tornier N.V. TRNX $19.31 $756 -1.98%7 ArthroCare ARTC $28.27 $778 -1.94%8 Zimmer Holdings ZMH $51.30 $9,192 -1.42%9 Kensey Nash KNSY $25.88 $224 0.66%

10 Smith & Nephew SNN $44.26 $7,907 1.10%

1 Medtronic MDT $34.38 $36,305 10.452 Zimmer Holdings ZMH $51.30 $9,192 10.893 Integra LifeSciences IART $29.56 $793 12.214 Smith & Nephew SNN $44.26 $7,907 12.865 Johnson & Johnson JNJ $64.12 $175,712 13.09

1 Wright Medical WMGI $15.27 $601 32.492 RTI Biologics Inc RTIX $4.51 $249 28.193 NuVasive NUVA $15.19 $642 22.674 Synthes SYST.VX $168.12 $19,969 21.285 ArthroCare ARTC $28.27 $778 19.77

1 Orthofix OFIX $34.17 $629 0.772 RTI Biologics Inc RTIX $4.51 $249 1.003 Zimmer Holdings ZMH $51.30 $9,192 1.174 Stryker SYK $48.56 $18,583 1.265 Exactech EXAC $15.55 $204 1.41

1 ArthroCare ARTC $28.27 $778 3.292 Kensey Nash KNSY $25.88 $224 3.063 Wright Medical WMGI $15.27 $601 2.714 NuVasive NUVA $15.19 $642 2.595 Johnson & Johnson JNJ $64.12 175,712 2.23

1 Symmetry Medical SMA $8.24 $299 0.832 Conmed CNMD $26.41 $737 1.033 Alphatec Holdings ATEC $2.05 $183 1.074 Exactech EXAC $15.55 $204 1.075 Integra LifeSciences IART $29.56 $793 1.08

1 TiGenix TIG.BR $1.10 $101 161.932 MAKO Surgical MAKO $37.44 $1,552 35.033 Synthes SYST.VX $168.12 $19,969 5.424 Bacterin Intl Holdings BONE $2.88 $114 4.975 Tornier N.V. TRNX $19.31 $756 3.33

PSR: Aggregate current market capitalization divided by aggregate sales and the calculation excluded the companies for which sales figures are not available.

http://www.ryortho.com/advertise.php


VOLUME 7, ISSUE 35 | NOVEMBER 8, 20114The Top Ten Best New Spine Technologies for 2011By Robin Young

Advertisement

The winners of the 2011 Orthope-dics This Week Best New Technol-

ogy Award for Spine are: Advanced Bio-logics, LLC, Aesculap, Inc., AlloSource, CoAlign Innovations, Inc., Ellipse Tech-nologies, Inc., NeuroLogica Corpora-tion, NLT SPINE, Nocimed, LLC, The Society for Minimally Invasive Spine Surgery and Thompson MIS.

This annual award rewards inventors, engineering teams, surgeons and their companies who’ve created the most innovative, enduring and practical products in 2011 to treat back pain. To win the Orthopedics This Week Best

New Technology for spine care, a new technology must meet the following criteria:

1. Be creative and innovative.

2. Have long-term significance to the problem of treating the diseases of the spine. Does this technology have staying power?

3. Solve a clinical problem. To what extent does this technology solve a current clinical problem or problem that is inadequately solved today?

4. Does it have the potential to improve standard of care?

5. Is it cost effective?

6. I would use it.

Our panel of surgeons scores every sub-mission on a scale of 1 to 5 (5 being the highest score) for each of the above criteria.

We and our panel of surgeons were impressed that inventors—despite ever growing hurdles to innovation and entrepreneurism in spine—still managed to create a solid group of new products to submit for the 2011 Orthopedics This Week Spine Technol-ogy Awards.

http://www.alphatecspine.com


VOLUME 7, ISSUE 35 | NOVEMBER 8, 20115We offer our thanks and deep appreciation to the engineering teams, surgeon inventors and the following companies for submitting their best ideas this year:

Our panel of surgeon judges was:

•Dr. Neel Anand: Director of Orthopaedic Spine Surgery at the Cedars-Sinai Spine Center•Dr. Scott Boden: Professor of Orthopedic Surgery and Director of the Emory Orthopaedics & Spine Center•Dr. Isador Lieberman: Medical Director of the Scoliosis and Spine Tumor Center and Orthopedic Surgeon with Texas

Back Institute •Dr. Ken Pettine: Co-Founder of Rocky Mountain Associates in Orthopedic Medicine and Co-Inventor of the Maverick™

Artificial Disc.

So, without further delay, here are the ten best new spine technologies for 2011 arranged in alphabetical order:

AccuLIF® Expandable Interbody Fusion Cage – CoAlign Innovations, Inc.AccuLIF is a crescent shaped, expandable Interbody Fusion (IBF) cage which is implanted by the surgeon using a transforaminal approach. The cage’s design incorporates a dual piston/cylinder shape and may be hydraulically expanded using sterile saline after being implanted by the surgeon. CoAlign created an articulating insertion handle for the surgeon to use to ensure optimal implant positioning between vertebral bodies. As the AccuLIF cage expands, a spring activated, automatic, locking mechanism locks the implant at 1mm increments. Finally, the engineers built into the implant a link between the two locking cylinders which ensures that the device will lock evenly. CoAlign is located at 150 North Hill Drive, Suite 1, Brisbane, California 94005. Phone: 760-683-4215.

AlloStem® Stem Cell Bone Growth Substitute– AlloSourceAlloStem is a living cellular allograft implant which is a unique combination of partially demineralized allograft bone and adipose derived mesenchymal stem cells. The material is designed to offer surgeons an alternative to iliac crest harvest or other autograft mate-rials for the surgical repair of boney defects. AlloSource’s proprietary processing system permits an intact partially demineralized allograft strip or cube to be implanted as a bridge between vertebrae. Allo-Stem is an osteoconductive scaffold, osteoinductive natural growth factors and living cells to support new bone formation. AlloSource is located at 6278 South Troy Circle, Centennial, Colorado. Phone: 720-382-2756

Advanced Biologics, LLC CareFusion K2M, Inc. NLT SPINE SI-BONE, Inc.

Aesculap, Inc. CoAlign Innovations, Inc. Life Spine, Inc. Nocimed, LLC SIGNUS Medical, LLC

AlloSource Ellipse Technologies, Inc. MEDICREA NuVasive, Inc. Society for MIS Surgery

Aspen Medical Products, Inc. Exactech, Inc. Minimus Spine Inc. OsteoMed LLC SpineWorks

Cardinal Spine, LLC joimax, Inc. NeuroLogica Corporation Ranier Technology Ltd. Thompson MIS

AccuLIF® ExpandableInterbody Fusion Cage

From left to right: Murali Kadaba – Chief Scientific Officer,

John Ashley – VP of R&D, andJohn Barrett – CEO

AlloStem® Stem Cell Bone Growth Substitute

From left to right: David White - Senior Product Manager,Kevin Cmunt - Senior Vice President,

Tom Cycyota - President and CEO, and Judy Lawten -

Vice President, Marketing

http://www.coalign.com/

http://www.allosource.org


VOLUME 7, ISSUE 35 | NOVEMBER 8, 20116BodyTom™ – NeuroLogica CorporationThe BodyTom is a battery powered, portable CT scanner—radiolucent spine table included—with impressive imaging power. The BodyTom transforms any operating room into an intraoperative spine imaging suite. BodyTom is a full body, 32 slice CT with an impressive 85cm gantry and a 60cm field of view. It is capable of imaging the entire spine, from C1 to S5 in one pass, providing the surgeon with high quality 3D images of both bone and soft tissue. Finally, the BodyTom easily interfaces with surgical navigation systems that accept DICOM images. Intraoperative images can be uploaded to surgical navigation via PACS connection, direct network cable link, wireless transmission or digital media transfer device (CD/USB). NeuroLogica is located at 14 Electron-ics Avenue, Danvers, Massachusetts 01923. Phone: 978-564-8500.

BoneBac Press – Thompson MISThe BoneBac press recycles bone collected from the surgical site dur-ing spine fusion surgery. BoneBac press improves upon the customary bone harvesting methods in several ways. Unlike traditional bone harvesting, BoneBac press keeps the harvested bone at the surgical site. Using a vacuum hose, the BoneBac pulls harvested bone into the press. Once collected, the surgeon can separate blood and fluid from the bone using the easy press system. BoneBac press is reusable and sterilizable. The system was designed to also work with allograft bone extenders. Finally, using the BoneBac press spine surgeons can significantly reduce if not elimi-nate secondary graft site morbidity. BoneBac Press’s inventor is Mick Perez-Cruet M.D., MS. He can be reached at [email protected]. Thompson MIS can be reached at [email protected] or 888-932-6949

Hydrolift Vertebral Body Replacement System – Aesculap, Inc.The Hydrolift Vertebral Body Replacement System uses hydrostatic pressure to expand and maintain distrac-tion of the disc space. Other expandable cages use a screw mechanism or ratchet style mechanical approach to achieve distraction. Because of this, other cages require a very high cross sectional area and therefore excess bone removal while performing the corpectomy. Since Hydrolift uses hydrostatic pressure and an exter-nal hydraulic pump, surgeons can preserve more of the patient’s host bone. Finally, the Hydrolift incorporates a failsafe mechanism in the hydraulic pump which limits the amount of pressure available to minimize or prevent endplate damage. Aesculap can be reached at 3773 Corporate Parkway, Center Valley, Pennsylvania 18034. Phone: 610-984-9242.

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From left to right: Greg Johnson, Alison Aviles, David Webster, Matt Dickman, CEO Dr. Eric Bailey, and Benjamin Powell

BodyTom™

From left to right: Robin Young-Publisher OTW and Mick

Perez-Cruet M.D., MS on behalf of Thomson MIS

BoneBac Press

From left to right: Larry Rubens-Vice President - Aesculap Implant

Systems Sales, Chuck DiNardo-President - CEO, Jeffrey Cole-

Director Spine Marketing, Gordon Young-Product Manager Spine, and Ira Benson-Vice President

Spine Marketing.

Hydrolift Vertebral Body Replacement System

http://www.neurologica.com/

http://www.thompsonmis.com/

http://www.thompsonmis.com/

http://www.aesculapinc.com


VOLUME 7, ISSUE 35 | NOVEMBER 8, 20117Magnetic Expansion Control (MAGEC™) – Ellipse Technolo-gies, Inc.The Magnetic Expansion system uses a cylindrical, radially-poled internal magnet to noninvasively lengthen or shorten an implanted rod. Early onset scoliosis patients have spinal deformity which is diagnoses before the age of ten. Surgically fusing the spines of these patients at such a young age creates an enormous risk of permanently undersizing the thoracic cavity and therefore reducing the amount of space for developing lungs and organs. Repeated surgeries to adjust rod length raises new problems. The MAGEC™ system solves this problem. The magnet inside MAGEC’s rods drives a lead screw which moves the two ends of the rod. The surgeon controls the magnet using an External Remote Controller (ERC). In a lengthening procedure the patient lies awake on an examining table. The ERC is placed on the patient’s back and within a few minutes the MAGEC rod has been non-invasively lengthened. If the patient feels discomfort, the rod can also be shortened until the discomfort disappears. Ellipse Tech-nologies may be reached at 13900 Alton Parkway, Suite 123, Irvine, California 92618. Phone: 949-837-3600.

Nociscan™ Virtual Discogram™ – Nocimed, LLCNociscan is a non-invasive test which distinguishes painful from non-painful lumbar discs and thereby better localizes the source of chronic, severe discogenic low back pain. Nociscan is a custom, pro-prietary software application that works in concert with commercially available Magnetic Resonance Spectroscopy (MRS) pulse sequence installed on standard, high field MRI systems. Nociscan’s proprietary protocols create a non-invasive exam to acquire chemical information from lumbar intervertebral discs. The data is processed to measure “disc pain biomarkers” in the discs that have been correlated to pain. Nociscan then uses a diagnostic algorithm based on measured bio-markers to generate a “Nociscore” which is useful for distinguishing painful from non-painful discs. Nocimed is located at the Plug and Play Tech Center, 370 Convention Way, Redwood City, California 94063. Phone: 650-241-1740.

OsteoAMP Structural – Advanced Biologics, LLCOsteoAMP is an allograft derived interbody spacer and granules which, according to the company, has more growth factors than DBMs and, in animal models, grows bone at a higher rate than stem cells or synthetics. The key to OsteoAMP is the process Advanced Biologics uses to create the material. Collagen subfibrils are swelled to increase growth factor binding sites. The growth factors contained within bone marrow are solubilized and the soluble growth factors then bind to the swollen collagen subfibrils. When the subfibrils are reduced back to their original size and configuration, they have a higher amount of BMP-2 than, for example, 100% DBM products. The process, in other words, significantly increases the growth factor content of the implant. Advanced Biologics is located at 555 Corporate Drive, Suite 260, Ladera Ranch, California 92694. Phone: 800-272-0267.

MAGEC™ External Remote Controller

(ERC)MAGEC™ Dual Rods

Nociscan™ Virtual Discogram™

James Peacock-CEO, Nocimed, LLC

From left to right: Scott Cadotte-VP Sales & Market-

ing, Amit Govil - President, and Jason Mattiello - Stategic Sales

& Marketing Manager

http://www.ellipse-tech.com/

http://www.nocimed.com

http://www.advancedbiologicscorp.com/index.php


VOLUME 7, ISSUE 35 | NOVEMBER 8, 20118PROW™ FUSION Intervertebral Body Fusion Device – NLT SPINEThe PROW device is a tool for distracting, preparing and fill-ing the intervertebral space less invasively (7mm width conduit) and thereby magnify the benefits of minimally invasive TLIF pro-cedures (shorter length of stay, shorter time to ambulation and lower overall cost). The key to the PROW is its unique conduit—which is really a kind of cannula, but with so much more engi-neering and capabilities that it is more accurately described as a conduit. The articulating conduit gives the surgeon the ability to insert and use large implants and surgical tools through a small incision. Because the tool articulates, it enters the body straight but then sequentially deflects at an accurate inflection point so as to form a predefined shape on the treatment site. NLT SPINE may be reached at 6 Yoni Netanyahu Street, Or Yehuda, Israel 60376. Phone: 972-3-634-4514.

SMISS Prospective Data Registry – Society for Minimally Invasive Spine SurgeryWhile not a specific implant, the role of data in improving patient selection, surgical plans and overall treatment protocols is as important—potentially even more so—than hardware or tech-nique. The Society of MIS Surgery (SMISS) (as well as NASS and AAOS) has committed to developing a registry program to col-lect data from surgeries, organize it and then provide it back to the surgical community. SMISS is conducting a multi-center pro-spective study of minimally invasive spinal surgery data for the treatment of degenerative lumbar spondylolisthesis, degenera-tive disc disease, spinal stenosis, disc herniation and degenerative scoliosis. This registry is the first large-scale, multi-center study of spinal fusion and endoscopic surgical method outcomes with minimally invasive spine surgery. For more information, please contact Kevin Liang Ph.D. at [email protected]. ◆

PROW™ FUSION Interverte-bral Body Fusion Device

From left to right: Robin Young-Pub-lisher OTW and Didier Toubia-Chief

Executive Officer

SMISS Prospective Data Registry

From left to right: Robin Young-Publisher OTW and Choll Kim

M.D., Ph. D.

http://www.nlt-spine.com/usa/

http://www.smiss.org/


VOLUME 7, ISSUE 35 | NOVEMBER 8, 20119Spine Fusion Reimbursement: Science or Politics? By Walter Eisner

There has been a fourfold rise in spine fusion treatments over the last

20 years. The higher expenditures have spurred an increase in clinical guide-lines and payer policies to determine appropriate treatments and payments.

But are the clinical guidelines consis-tent with each other? Are payer policies developed by consultants like Milli-man operating under the same rigor-ous transparent and consistent research requirements used to develop clinical guidelines? Are biased payer policies superseding physician determination?

A recent study published in Spine (SPINE Volume 36, Number 21S, pp

S144–S163) sought to answer these questions.

Comparing Quality of Evidence

Joseph S. Cheng, M.D, MS, and his colleagues (Michael J. Lee, Eric

Massticotte, Bryan Ash-man, Marcelo Gruen-

berg, all M.D.s, and Leslie E. Pilcher, MPH, BA, and

Andrea C. Skelly, Ph.D., MPH), sought to compare

the quality and evidence base of fusion guidelines and select payer policies in a study

called: “Clinical Guidelines and Payer Policies on Fusion for the

Treatment of Chronic Low Back Pain.”

They began with the premise that the need for surgery based on lit-erature is beginning to supersede

physician determination. Since guide-lines and policies have impact on the definition of “medical necessity,” they decided to test the quality of those poli-cies and guidelines.

“Payer policies define medical necessity and should be held to the

same standards for transparency and development as guidelines,”

wrote the authors.

The study’s authors looked at PubMed, the National Guidelines Clearinghouse and the International Network of Agen-cies for Health Technology Assessment. They also searched Google for payer policies. They used an Appraisal of Guidelines Research and Evaluation instrument to provide a method for evaluating the quality of development of the evidence base.

Photo Creation by RRY Publications/Morguefile

EFFECTS OF GUIDELINES AND PAYER POLICIES

S144 www.spinejournal.com

October 2011

SPINE Volume 36, Number 21S, pp S144–S163

©2011, Lippincott Williams & Wilkins

Clinical Guidelines and Payer Policies on Fusion

for the Treatment of Chronic Low Back Pain

Joseph S. Cheng , MD, MS , * Michael J. Lee , MD , † Eric Massicotte , MD , ‡ Bryan Ashman , MD , §

Marcelo Gruenberg , MD , ¶ Leslie E. Pilcher , MPH, BA , || and Andrea C. Skelly , PhD, MPH ||

Study Design. Systematic review.

Objective. The purpose of this review is to provide a critical

appraisal of general and fusion–speci c clinical practice guidelines

on the treatment of chronic nonradicular low back pain and compare

the quality and evidence base of fusion guidelines and select payer

policies. Summary of Background Data. The treatment of lumbar

spondylosis associated with low back pain with lumbar arthrodesis, or

fusion, has risen fourfold in the past two decades. Given the signi cant

associated health care costs, there is an increase in clinical guidelines

and payer policies in uencing patient treatment options. Assessment

of the medical necessity of a treatment, such as lumbar fusions, based

on medical literature will frequently supersede the determination

of the physician in the care of their patient. Concerns regarding the

effectiveness and costs of the surgical treatment of spinal disorders

presenting with low back pain has placed enormous scrutiny on the

value of surgical treatments to our patients. As both clinical guidelines

and payer policies have a major impact on the perceived effectiveness,

or medical necessity, of lumbar fusions for the treatment of chronic

nonradicular low back pain, a review of this topic was undertaken.

From the * Department of Neurological Surgery, Vanderbilt University Medical

Center, Medical Center North, Nashville, TN ; † Department of Orthopedics,

University of Washington Medical Center, Seattle, WA; ‡ Division of

Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, ON;

§ Director of Surgery, Canberra Hospital, Canberra, Australia; ¶ Institute of

Orthopaedics Carlos E. Ottolenghi, Italian Hospital of Buenos Aires, Buenos

Aires, Argentina; and || Spectrum Research, Inc., Tacoma, WA .

Acknowledgment date: May 7, 2011. Acceptance date: July 21, 2011.

The manuscript submitted does not contain information about medical

device(s)/drug(s). Professional organization and foundation funds were received to support this

work. No bene ts in any form have been or will be received from a com-

mercial party related directly or indirectly to the subject of this manuscript.

Analytic support for this work was provided by Spectrum Research, Inc., with

funding from the AO Spine, North America.

J.S.C. contributed to topic development, general oversight of article, data ab-

straction, policy collation, review, and primary writing. M.J.L. and E.M. con-

tributed to policy collation, contribution to introduction and discussion. B.A.

and M.G. contributed to discussion. A.C.S. contributed to methods develop-

ment (including modi ed appraisal tool), synthesis of results, contribution to

discussion, general oversight of methods, and data abstraction and synthesis.

L.E.P. contributed to literature search, information synthesis for general guide-

lines results, and collation of guideline recommendations. All the authors ap-

proved the nal draft of manuscript.

Address correspondence and reprint requests to Joseph S. Cheng, MD, MS,

Vanderbilt University Medical Center, Medical Center North, Nashville, TN

37232; E-mail: [email protected] .

Methods. An electronic literature search of PubMed, the National

Guideline Clearinghouse and the International Network of Agencies

for Health Technology Assessment was performed to identify

clinical practice guidelines on assessment and treatment of chronic

nonradicular low back pain, including those on use of lumbar fusion,

as well as relevant technology assessments. A Google search for

publicly available private and public payer policies related to fusion

was also performed. A hand search was used to identify speci c

studies cited for support of the recommendations made. A modi ed

Appraisal of Guidelines Research and Evaluation instrument was

used to provide a standardized assessment method for evaluating the

quality of development of the evidence base and recommendations

in guidelines and selected health policies. This was combined with

appraisal of the evidence base supporting the recommendations.

Results. Three systematic reviews of general guidelines from a

PubMed search yielding 94 citations were included. A convenience

sample of ve guidelines with recommendations on fusion was

taken from 182 citations identi ed by the National Guideline

Clearinghouse and the International Network of Agencies for Health

Technology Assessment searches. Two guidelines were developed by

US professional societies, (neurosurgery and pain management), and

three were European-based guidelines (Belgium, United Kingdom,

and the European Cooperation in Science and Technology). The

general guidelines were consistent with their recommendations

for diagnosis, but inconsistent regarding recommendations for

treatment. All guidelines and payer policies with recommendations

on fusion included some set of the primary randomized controlled

trials comparing fusion to other treatment options with the exception

of one policy. However, no clear pattern with regard to the quality

of development was identi ed based on the modi ed Appraisal of

Guidelines Research and Evaluation tool. There were differences in

specialty society recommendations.

Conclusion. Three systematic reviews of evidence-based guidelines

that provide general guidance for the assessment and treatment of

chronic low back pain described consistent recommendations and

guidance for the evaluation of chronic low back pain but inconsistent

recommendations and guidance for treatment. Five evidence-based

guidelines with recommendations on the use of fusion for the treatment

of chronic low back pain were evaluated. There is some consistency

across guidelines and policies that are government sponsored with

regard to development process and critical evaluation of index

studies as well as overall recommendations. There were differences

in specialty society recommendations. There is heterogeneity in

the medical payer policies reviewed possibly due to variations in

the literature cited and transparency of the development process. A

DOI: 10.1097/BRS.0b013e31822ef5b4 Copyright © 2011 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

BRS204660.indd S144

16/09/11 10:18 PM

Clinical Guidelines and Payer Policies on Fusion for the Treat-ment of Chronic Low Back Pain

http://ryortho.com/Clinical_Guidelines_and_Payer_Policies_on_Fusion131.pdf


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201110The authors found that the general guidelines published through January 2011 were consistent with diagnosis, but inconsistent about treatment rec-ommendations.

Study Conclusions

“Three systematic reviews of evi-dence-based guidelines that provide general guidance for the assessment and treatment of chronic low back pain described consistent recom-mendations and guidance for the evaluation of chronic low back pain but inconsistent recommendations and guidance for treatment.

Five evidence-based guidelines with recommendations on the use of fusion for the treatment of chron-ic low back pain were evaluated. There is some consistency across guidelines and policies that are gov-ernment sponsored with regard to development process and critical evaluation of index studies as well as overall recommendations.

There were differences in specialty society recommendations. There is heterogeneity in the medical payer policies reviewed possibly due to variations in the literature cited and transparency of the development process.” [Emphasis added.]

Or put another way, while the guidelines emanating from the surgeon societies are consistent in terms of diagnosing spinal disorders, they are inconsistent with regards to its treatment. Therefore the payers develop inconsistent pay-ment policies and are able to pick and choose the guidelines that are in their best financial interest.

“This has led to the development of payer policies to temper the rise in

health care utilization that appear to conflict with local standard of care and clinical guidelines. Physi-cians who specialize in spinal care have found themselves challenged to provide their patient with what they believe to be the most appropriate and beneficial care in an increasing-ly difficult financial environment with decisions increasingly influ-enced by the conflicting interests of doctors, hospitals, and insurers. Such conflicts have raised questions on what constitutes the standard of care for a patient, and what defines the best available evidence to sup-port it.” [Emphasis added.]

Physician Response

David Polly, M.D. and head of spine services at the University of Minnesota told OTW that insurers/payers need to be as transparent as they are asking the surgeons to be about guideline develop-ment and treatment recommendations.

“There is a presumed bias that payers will deny coverage in the absence of overwhelming data to demonstrate effi-cacy—a perpetually moving target. In order to preserve their own reputation they [insurers] may need to be even more forthcoming and err on the side of coverage rather than non-coverage since they are innately conflicted towards non-coverage,” said Polly.

“Also at some point it should become a customer’s right to know how and what their coverage decision process is. Oth-erwise the presumption is that they are all like the Grisham novel/movie ‘Rain-maker’.”

Societies Respond

Speaking on behalf of the North Ameri-can Spine Society (NASS), Chris Bono, M.D., told us that the study highlights how guidelines are being used inconsis-tently. “It points out that society data guidelines are not making it into

Doctors Gunnar Andersson and Chris Bono (left to right)


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201111payer guidelines. So payers are pick-ing and choosing and are somewhat biased,” said Bono.

Gunnar Andersson, M.D., chair of the ISASS (The International Society for the Advancement of Spine Surgery) Public Policy Committee said the study “raises concerns and also illustrates the lack of rigor and transparency in creating guidelines and performing health technology assessments.”

He noted the study’s finding of incon-sistencies in treatment recommenda-tions between guidelines created, for example, by the American Pain Society and the Neurosurgical Societies and varying conclusions drawn by studies reporting outcomes following fusion surgery for degenerative conditions

“Most published reviews focus on the systematic review of primarily random-ized controlled trials (RCTs). While these studies represent the highest level of evidence available, RCTs are not always feasible or practical to address surgical treatments. In addition, pub-lished studies are not reflective of more current fusion surgical techniques,” added Andersson.

Andersson said the remaining body of literature provides value to the evi-dence-based medicine discussion and is often discounted during the guide-line development process.

Payer Policy Discrepancies/Lack of Transparency

A more serious concern, said Anders-son, arose when reviewing medical payer policies, “which revealed a high level of heterogeneity not only in rec-ommendations, but also in the devel-opment process. Discrepancies were

found in the evidence used for policy development and there was a gener-al lack of transparency. Some payer policies are based on guidelines that are not publicly available for review.”

While agreeing that there is always room for greater efficiencies, Anders-son said, “Spine fusion surgeries are increasingly being based on non-transparent assessments provided by consulting firms based on accounting principles, without input from the physician community or the totality of the evidence-based literature.

Payer Variations

For real world examples we went to Jeff Zigler, J.D., a reimbursement expert at MCRA (Musculoskeletal Clinical Regu-latory Advisers. LLC). Zigler has noted variations (read: inconsistencies) in the standard of review for different thera-

pies, by at least one national health plan: United Healthcare (UHC).

He said this wasn’t just an issue with fusion and cited the case of UHC’s pol-icy of non-coverage for lumbar artifi-cial disc replacement. “Such a policy of non-coverage seems unfair, in light of the robust randomized, controlled clin-ical trials supporting PMA [pre-market approval] approval of the Charité as early as 2004 and consistent data with published outcomes representing Lev-els I and II Evidence to support UHC’s coverage,” said Zigler.

Continued Zigler, “UHC’s policy on artificial disc replacement, which states in the relevant part, ‘Lumbar artificial total disc replacement is unproven for the treatment of single or multiple level degenerative disc disease in skel-etally mature patients,’ is based upon

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VOLUME 7, ISSUE 35 | NOVEMBER 8, 201112an inconsistent standard of review internal to the payer.”

In another example, Zigler said UHC coverage decisions for drug-eluting cardiac stents (DES) and bariatric sur-gery reveals inconsistencies regarding life-saving and life-enhancing therapy assessments.

“Despite demonstrating statistical sig-nificance in many objective categories of efficacy, sufficient to meet non-infe-riority endpoints, UHC generally cov-ers the use of DES, but specifically will not cover artificial disc replacement. Moreover, the medical community’s misgivings about late stent thrombo-sis in DES patients continue to prompt further investigation, and question the long-term durability of DES—yet UHC covers DES in the interim, while those studies are conducted. This UHC ‘interim coverage’ policy for novel, effi-cacious technology undergoing addi-tional review and investigation has not been extended to disc.”

Lessons From Bariatrics

Zigler says that UHC also seems to be remiss in seriously considering its option of covering cases performed at qualifying Artificial Disc Centers of Excellence, as in the case of bariatric facilities performing Lap-Band. “Per-haps NASS, ISASS, AANS [American Association of Neurological Surgeons] and CNS [Congress of Neurological Surgeons] should take a page out of the playbook that professional bariatric societies used to secure limited Lap-Band coverage (American Society for Bariatric Surgery; Society of Gastroin-testinal Endoscopic Surgeons).”

“This might at least secure coverage for qualifying centers, and would have the ancillary benefit of tracking patient

outcomes from around the country. Even if a Center-of-Excellence model is impracticable, payers like UHC could still allow coverage while the evidence for artificial disc replacement develops, which has clearly been afforded to other technologies like DES.”

An Imperative for Physician Role

The authors of the study warn that transparency and complete disclosure of potential bias is required for cred-ibility and compliance with any rec-ommendations. “A patient, physician, hospital, or payer must have complete confidence in the recommendations generated by any authoritative organi-zation with respect to determining what is considered appropriate and benefi-cial medical care.”

Unfortunately, say the authors, at this time, there seems to be a void and

they feel that there is a pressing need for this in the era of health care reform and value-based medicine. “Otherwise, the care of our patients may be dictated

more by economics and politics, than by what may be best to help our patients and ensure access to beneficial medical care. The authors of this article believe that as physicians it is imperative that we play a pivotal role in this.” ◆

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VOLUME 7, ISSUE 35 | NOVEMBER 8, 201113Orthopaedic Crossfire® Tackles Metal on MetalBy Elizabeth Hofheinz, M.P.H., M.Ed.

Image created by RRY Publications, LLC. Source: Wikimedia - KaihsuTai and Current Concepts in Joint Replacement

TopicMetal-Metal: A Twilight Zone Where

Weird Things Happen

For the Proposition:Joshua J. Jacobs, M.D.

Rush Orthopaedic InstituteChicago, Illinois

Against the Proposition:Thomas P. Schmalzried, M.D.Joint Replacement Institute

Los Angeles, California

Moderator: Thomas S. Thornhill, M.D.

Harvard Medical SchoolBoston, Massachusetts

Dr. Jacobs: “What better way to enter the twilight zone than to quote my favorite philosopher, Donald Rums-feld…“There are known knowns, there are things we know we know, we also know there are known unknowns, etc.” It’s the unknown unknowns that have been the Achilles heel with some of these reconstructions. It’s not all

bad news…there are published stud-ies with promising intermediate term results with both metal on metal (MoM) total hips and surface replacements. However, there are multiple reports of osteolysis aseptic loosening, soft tissue masses in MoM total hip replacement systems and also surface replacements that are possibly associated with hyper-sensitivity. To understand this we need to understand the fate of the debris that is generated from MoM bearings because I think this determines the ulti-mate soft tissue and local response. Not


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201114only do we have to deal with particles from wear but also free metallic ions that come off as a result of corrosion and colloidal organometallic complexes that form from these ions complexing with local proteins.”

“Metal particles: we don’t know as much as we’d like. One MoM retrieval study showed that most of these par-ticles are less than 50 nanometers. This is an order of magnitude smaller than polyethylene particles…meaning that even though the volumetric wear rate might be less with MoM, the number of particles produced may be up to three orders of magnitude higher depending on what sizes you use for the calcula-tion. It has also been shown that the chrome to cobalt ratio in periprosthetic tissue is reversed. It should be 1 to 2 in the alloy and it’s 9 to 1 or 5 to 1, depending on how you measure it…so what you’re actually seeing in the tis-sues is a preponderance of corrosion products—either those precipitated from metal ions or those from the nano debris that have been generated.”

“Metal ions: we have found, as have other labs, that there are elevations of 10 20-fold in patients that have MoM bear-ings. But we don’t know if there is any toxicity. Acute toxicity reported is rare, but there are reports from the UK show-ing a higher chromosomal aberration rate in patients with MoM bearings…but the clinical significance is unknown and whether this is related to long term carcinogenesis is unclear. Data from our lab and others have shown that patients with MoM bearings do have a higher rate of hypersensitivity; the cytokine profile shows high levels of interferon gamma and IL-2, which are the signa-ture cytokines for a Th1 response. This specific response leads to pro-inflam-matory mediators that can actually upregulate the whole innate immune system leading to what I would call a

hypersensitivity induced osteolysis. This is different from the typical particle associated osteolysis…this may actually be mediated by a hypersensitivity reac-tion. Why discuss this? Because we are starting to see reports of these lympho-cytic tissue reactions in these modern generation metal on metal bearings.”

“In one study, pseudo-tumors were reported in 17 patients with 20 hips; the histology reveals necrosis and lym-phocytic infiltration. This is a case of a pseudo-tumor, not with a MoM bearing but with a highly corroded stem show-ing necrosis of the tissues, the bone, and the corrosion products of massive necrosis. As was the case with ceramics, with MoM we can’t throw out the baby with the bath water.”

Dr. Schmalzried: “With regard to met-al-metal the benefits include high sta-bility and low wear; they’re unbreak-able, and they form the foundation for a higher performance arthroplasty. There is a risk…a rare adverse local tissue response. And then there is the ‘compared to what?’ We’ve heard the debate on cross linked polyethylene and ceramic on ceramic…there is no risk free alternative.”

“It’s no mystery why both surgeons and patients have embraced metal-metal bearings. The high stability favors the larger diameter; metal-metal bearings work better and have lower wear as the diameter goes up…that gives you a higher, impingement free ROM and greater jump distance…. And it enables resurfacing. There’s already documen-tation of very low wear in vivo for more than 30 years and no evidence of gross material failures.”

Showing a video of a rock climber, Dr. Schmalzried stated, “This is a patient in my practice who said, ‘Rock climbing is my passion, but I can’t do it anymore.

Do you have a total hip that would allow me to return to rock climbing?’ We used a bilateral, 36mm on a stan-dard new small generation trunion, giv-ing him the ROM, stability, and strength he would need.”

“There are more than 400,000 sec-ond generation implants worldwide with more than 20 years of follow up. There are several reports indicating no discernable difference in pain relief or clinical outcomes; and if you have a less than 5mm thick mono-block cup it conserves bone. You can’t accomplish that with an ingrowth surface using either polyethylene or ceramic.”

“Even within manufacturers there is variability in the process. The formula for low wear involves high carbon, large diameter, and small clearance; if it’s well made and well mated, it will do well. It’s good in young patients; high activity does not influence ion levels. What does

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VOLUME 7, ISSUE 35 | NOVEMBER 8, 201115influence ion levels is urine volume. Quite simply, chromium excretion is a function of urine volume; if your patients want to decrease their circulat-ing levels of ions, they should drink a lot…. They will pee a lot, and they will pee out their ions.”

“You’ve heard that vertical cups don’t do well with cross linked poly; you’ve heard that malpositioned vertical cups don’t do well with ceramic on ceram-ic…. The same is true for metal-metal. Higher wear is associated with verti-cal component positioning. The risk of high ion levels goes up with verti-cal component positioning; you need to avoid components at 55 degrees or higher regardless of the bearing. Large diameter does not compensate for verti-cal positioning, and there is some data indicating that excessive combined anteversion has a similar effect.”

“What determines serum ion level? Component orientation (avoid verti-cal positioning); the loads and motion patterns will be different from patient to patient; the lubrication regime can be different; the wear mechanism, the presence or absence of any third bodies; non-bearing sources such as impinge-ment and taper corrosion; and the ion excretion rate.”

“Pseudo-tumors are not a new phe-nomenon. We need more information on the role of mechanics, and the role of corrosion. What is the incidence worldwide? There appear to be some centers that have a high incidence and other centers with a low incidence. My personal experience, through April 2008 with 571 hips having at least a 36mm bearing is that I have one patient with bilateral surface replacements who developed ALVAL [aseptic lymphocyte dominated vasculitis associated lesion].

I participated in three metal-metal sur-face replacement IDEs [investigational device exemption] with greater than 2,500 hips, minimum two year follow up; none of those have been revised for an adverse immune response.”

“I don’t want anyone to think that I’m not concerned about the rare local immune response. If there is anything weird going on it has to do with the fact that the incidence appears to be quite variable from center to center and region to region. We must identify risk factors from an implant, patient, and surgical technique perspective. But it is my position that if a bearing is well made and well mated it will do well.”

Moderator Thornhill: “Tom, which is more high performance, a convention-al femoral stem, large head, metal on metal, or a resurfacing?”

Dr. Schmalzried: “This isn’t a debate about resurfacing. You can get the same level of performance from either type of arthroplasty if the reconstruction is mechanically done well.”

Moderator Thornhill: “Josh, do you do use MoM hips?”

Dr. Jacobs (hesitating): “Uh, no.”

Moderator Thornhill: “Tom, what do you tell your patients about the down-side of a MoM hip?”

Dr. Schmalzried: “I make sure they understand that there are possible local tissue reactions…and I tell them that I’ve only had one such case.”

Moderator Thornhill: “Josh, what are you doing now and what can you tell us from your results so far?”

Dr. Jacobs: “We should distinguish pseudo-tumors from metal hypersen-sitivity. It’s unclear what the pathogen-esis of these pseudo-tumors are, and to what extent they may or may not be related to hypersensitivity. We’ve seen pseudo-tumors around metal on polyethylene. But it seems to be more prevalent with metal on metal (anec-dotally). In terms of systemic testing, there are various ways that we have tried in a laboratory to determine whether the patient might be hyper-sensitive to metal, but that may or may not be predictive of whether they get a pseudo-tumor. This is going to require extensive research…and we should try to get an idea if there are some periph-eral markers that can identify them even before surgery.”

Moderator Thornhill: “Tom, I know everyone in southern California wears 24 carat gold, but the bling in Boston has a lot of alloys. When you have a patient saying they have metal sensitiv-ity, what do you do?”

Dr. Schmalzried: “I screen for overall allergic history and a cutaneous metal allergy history specifically. If someone has a long list of allergies I tell them, ‘I think that you’d be better off with an implant that doesn’t have cobalt chromium molybdenum nickel alloy. If someone says they have a ring or bracelet that gives them a rash or red-ness I say, ‘I think you’d be better off with something that doesn’t contain that alloy.’”

Moderator Thornhill: “It’s a prob-lem…I agree.”

Dr. Schmalzried: “But it may be one of the reasons why it’s low in my prac-tice because I’ve avoided people with an allergic propensity.”



Moderator Thornhill: “I solve it by not doing metal on metal and sending the patient to someone who does. Josh, if you’re going to do metal on metal should you avoid modular stems?”

Dr. Jacobs: “The problem with implant debris and metal debris in particular is that the effects can be cumulative and additive—and may be synergistic. The trouble with modular stems is that that

(modular junctions) can be an addi-tional source of debris generation. And in addition the debris generated from these can accelerate third body wear at the articulation. So I’m afraid that we may see even more complications in those reconstructions that have more than one or two modular junctions, so it’s something to avoid if at all possible.”

Dr. Schmalzried: But there’s no data at this point to indicate that the risk is increased, right, because all the surface replacements are monoblock implants?”

Dr. Jacobs: “There is no clinical data yet; however the current generation of some of these modular neck body stems has not been around long enough to generate that data.”

Moderator Thornhill: “Tom, concern-ing systemic toxicity, people say ‘don’t do it in a woman of childbearing age or someone with renal failure.’ What are the things that you avoid in terms of systemic toxicity?”

Dr. Schmalzried: “There’s no reason to do it in a patient with renal failure. If it’s a woman of childbearing age, I have a frank discussion with the patient about whether the benefits outweigh the risks. In the resurfacing trials we’ve had a number of women who became pregnant, went to term, and delivered healthy babies, so again we have not seen a problem in that age group.”

Moderator Thornhill: Thank you both. ◆

Please visit www.CCJR.com to register for the upcoming 2011 CCJR Winter Meeting, December 7-10 in Orlando, Florida and the 2012 CCJR Spring Meet-ing, May 20-23 in Las Vegas, Nevada.

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Reporter’s NotebookBy Elizabeth Hofheinz

Wikimedia Commons

Dear OTW Reader:

“Committee of 12” with a bull’s-eye on healthcare? New hires at K2M…out of the way, FDA…What Peter Indelicato, president of AOSSM, is excited about, and oh,…hear what happens when some Viscogliosis go hunting. (Hint: no one was shot in a small bone)

Hospitals, Nonpayment, and Hyper-caution Dr. Donald Shelbourne, founder of the Shelbourne Knee Center in Indianapolis, tells OTW, “There is a lot of talk about ‘the checklist mani-festo’ these days…meaning, that soon Medicare will put its foot down and will not pay hospitals for the cost of treat-ing preventable complications. The cost of treating an infection is ten times the cost of a total knee. So hospitals are now on alert, and more than ever are trying to ensure that nothing happens that is preventable. Hand sterilization is being stressed more than ever, and at least one hospital I know of has imple-mented a rule that the plan for a patient must be reviewed in the holding area before surgery so as to prevent things such as wrong site surgery…and it’s a surgeon, not a fellow, who has to sign the site. These things are clearly what we have needed for a long time. And the wave is such that once Medicare starts saying they absolutely won’t pay for preventable conditions, then all the other insurers will as well. It’s going to make everyone even more cautious. Take DVT [deep vein thrombosis]…if someone develops a clot and the per-son had not been on an anticoagulant,

then that is preventable…and it won’t be covered.”

The spine masters at K2M, Inc. have brought three new senior internation-al hires on board. Larry W. Found, senior vice president, global human resources, has more than 20 years expe-rience in the medical device industry. Found was formerly a Captain in the Canadian Army, a role which included commitments to the UN and NATO. Gianluca Iasci, senior vice president of international, also has more than two decades of experience within the medical device industry. Iasci served as senior vice president of international at AGA Medical and served for 12 years with Johnson & Johnson in various Ital-ian and European sales and marketing positions. He also was the managing

director of Italy while at Guidant, now Boston Scientific. Carol Pinto, area vice president, Latin America, has more than 25 years of experience in sales and marketing leadership for companies in the spine and medical implant industry including Orthofix Spine (Blackstone Medical) and Surgical Dynamics, Envi-sion.

Keeping Young Athletes in the Game Peter Indelicato, M.D., president of the American Orthopaedic Society for Sports Medicine, tells OTW, “Sports medicine specialists are excited that the STOP Sports Injuries campaign (www.stopsportsinjuries.org) is starting to develop a life of its own. We have had a huge increase in member involvement and growing corporate sponsorship…it’s not hard to support this program…

http://www.stopsportsinjuries.org


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201118it’s like apple pie and the American flag. Who wouldn’t want to support a seri-ous, coordinated effort to diminish the frequency and incidence of injuries in young athletes? The most exciting thing is that we are keeping kids ‘in the game’ for life. Sometimes the game doesn’t like kids as much as kids like the game, but I am proud to say that we are chang-ing that.”

Wright: New Senior VP and COO And the bullhorn goes to…Julie D. Tracy. Tracy is the new senior vice pres-ident and chief communications offi-cer at Wright Medical Group, Inc. She brings more than 25 years of experience in the medical device industry in inves-tor relations, corporate communica-tions and marketing. She has been chief communications officer for Epocrates, Inc. and senior vice president and chief communications officer for ev3 Inc.;

she has also held marketing and inves-tor relations positions at Kyphon Inc. and Thoratec Corporation.

Improving Spine Care in Africa Saving spines and livelihoods in the Congo…Richard Kaul, M.D. is the founder of New Jersey Spine & Rehabil-itation in Pompton Lakes, New Jersey. In his “other life,” he is the creator of the Spine Africa Project, a project bringing more advanced spine care to the Congo. Dr. Kaul is not only performing surgery and educating healthcare providers, he is helping to support patients eco-nomically. How? Because if the family breadwinner sustains a serious injury they often cannot work; they and their families can become destitute and can no longer contribute to their communi-ties. Dr. Kaul is raising money to begin bringing equipment, such as a backup generator and sterilization equipment,

to the Congo. The Spine Africa Project is holding its first fundraiser in New York on Nov. 12, with the hopes of rais-ing enough funds to cover its December trip. Those interested in learning more about the project can visit the website at www.spineafricaproject.org/

Transition for Bill Sterett, M.D. Bill Sterett, M.D., former managing part-ner of the Steadman-Hawkins Clinic, has joined the practices of Vail-Summit Orthopaedics. The knee and shoulder specialist has been treating patients in the Vail Valley for more than 18 years. Dr. Sterett, one of the few Colorado sur-geons fellowship-trained in both sports medicine and orthopedic trauma, has been the U.S. physician for past three winter Olympics and seven World Alpine Ski Championships. He is also the author of 30 peer-reviewed publi-cations and has patents on some of the most commonly used joint preservation systems in orthopedics.

Gunning for Healthcare A certain vet-eran orthopedist thinks that the govern-ment’s “Committee of 12” has a bulls-eye on healthcare…this surgeon tells OTW, “Healthcare expenditures exceed defense expenditures—and almost any other piece of pie—so it’s unlikely that we won’t see cuts. The Medicare popu-lation will be increasingly left out if the committee goes through with the large cuts they are planning. Specialists in particular will soon be opting out of Medicare; granted, we could end up with a situation where a certain por-tion of a doctor’s time is legally allo-cated to Medicare patients. But, from the patient’s perspective, no one wants to see a physician who doesn’t want to see them. If they go ahead and reduce reimbursement rates by 6% a year for three years, that’s one thing. But that’s not the case…they’re not saying, ‘We’re

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VOLUME 7, ISSUE 35 | NOVEMBER 8, 201119in trouble today, but we’ll give it back to you in a year.” They are saying, ‘We are in trouble today, but we’re never giving it back.’ You know that wouldn’t hap-pen to lawyers, postal workers, etc.”

North Shore Expands NorthShore University HealthSystem in Illinois has welcomed the physicians of Northwest-ern Orthopaedic Institute, LLC (NOI) into its system of care. In the past year, NorthShore has added 12 physician practices and more than 40 new physi-cians and thousands of patients. Part of this integration is a planned joint neu-rologic and orthopedic spine care pro-gram. “This partnership will enhance the future of spine care by offering comprehensive expertise and the lat-est technology and treatment including operative, non-operative and minimally invasive options,” said Srdjan Mirkovic, M.D., NOI spine surgeon, in the news release.

FDA a Hindrance A certain frustrated orthopedist could not contain his annoy-ance. He recently told OTW, “The FDA has raised the bar for new devices and biologics to the level where it is nearly impossible for new safe technologies to emerge for the benefit of our patient. There are viable emerging technologies languishing…technologies that could otherwise help suffering patients. But this monolithic entity is creating such awful, and at times, irrational, road-blocks that it is nearly impossible to overcome them in contemporary medi-cine and economics. Even well-funded and intended projects are having prob-lems. As a general rule, if the FDA can implement rational guidelines, then funding and research would likely lead to viable technologies to solve very dif-ficult clinical problems that continue to plague our patients. Concerns for job preservation may exceed concerns for

evolutionary and safe developments of emerging technology.”

A Viscogliosi Goes A Huntin’ Armed with experience in backwoods Michi-gan—oh, and a large rifle—John and Marc Viscogliosi (now city boys)—recently went on a hunting excursion with a friend. John Viscogliosi told OTW, “We were out in Colorado, and it was our first time elk hunting. The first day we saw a large elk but we didn’t get in any shots. On the second day I spot-ted an elk in a thicket of Aspen trees. Our friend saw the rack on the elk and said, ‘You have to get this one.’ I was about 80 yards away…and I actually dropped it in one shot. Apparently, this is exceedingly rare. Our hunting mate told me that of the 36 elk he had got-ten in the last four years he had only dropped one with a single shot. The antlers are soon to be delivered to my

office in New York, something that should liven up business discussions. As for the meat, it was processed into sausage, roast jerky, etc.”

Rothman Participates in New Sur-gery Center Riddle Surgical Center, a multi-specialty ambulatory surgery center located in Media, Pennsylvania, has recently celebrated its first anniver-sary. The center was developed by area physicians, Main Line Health Systems, The Rothman Institute, and Nueterra Healthcare to provide patients with high-quality, patient-focused surgical care. The 17,500-square-foot facility offers four fully-equipped operating rooms and two procedure rooms with the latest medical instrumentation. In addition to orthopedic surgery, it is equipped for ENT, Gastroenterology, General Surgery, Ophthalmology, Pain Management, and Podiatry. ◆

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Smith & Nephew Revenue Grows 10% in 3Q11 TABLE

Led by knees, Smith & Nephew reported on November 4 that com-

pany revenue grew 10% in the third quarter to $1.032 billion.

On a constant currency basis, knees rose 6%, while the hip business shrank by 2%, reflecting concerns about met-al-on-metal technology. Trauma was up 4%

Orthopedic sales (consisting of recon-struction, trauma and clinical thera-pies) grew by 1% in the U.S. and 6% outside the U.S.

Reconstruction revenues grew by 2%, ahead of, according to the company, the estimated global market growth rate of 1%. It was the company’s fifth consecu-tive quarter of market outperformance. In the U.S., growth was flat, while out-side the U.S., sales grew 5%. In Europe, growth was 2%.

The company said the global knee fran-chise delivered market-leading growth driven by a strong portfolio of implants and instruments. In the U.S., the growth rate eased to 5%, partly reflecting the annualizing of new products launched last year, while outside the U.S., the company saw a 6% increase in sales.

The slip in the global hip business was attributed to continued strong head-winds of the company’s Birmingham Hip Resurfacing System (BHR). This, says the company, was despite the con-tinuing strong data on BHR, where

recent registry data in Austra-lia and NICE data in the UK demonstrated industry-lead-ing high long-term surviv-

ability. In traditional hips, the company saw double-digit growth in revenues from products featuring the proprietary Oxinium bearing surface.

The 4% trauma growth was against an estimated market rate of 6%. The com-pany said it saw strong growth in sales for the Limb Restoration external fixa-tion devices and internal fixation ranges such as Trigen Intertan nails and the Peri-Loc Variable-Angle Locked Plating System.

Clinical therapies’ revenues grew 7% with the Exogen Bone Healing System growing strongly.

The story in orthopedics however, was pricing pressure that reduced the com-pany’s margins down to 15.6%. The shrinking margin was attributed by the company to continuing adverse sales mix, high periodic costs, and the need

to reduce costs to better reflect market conditions.

Bohuon Comments

Olivier Bohuon, who became chief execu-tive in April, said he was “disappointed” with the margin. “Our cost base in orthope-dics was too high,” he told reporters on November 4 analysts conference call. “We have to adapt to meet market challenges—

we are all seeing lower growth and greater pricing pressure. We have been addressing this issue but we did not do this fast enough.”

The company said it still expected to grow full-year revenue in orthopedic reconstruction, sports medicine and advanced wound management faster than the market.

Bohuon concluded, “In August we announced our new strategic priorities to maximize growth and margins. The new operational management teams have embraced these and together we are developing the action plans that will liberate the resources needed for re-investment and to protect our under-lying margins. With high levels of ener-gy and determination, we are reshap-ing Smith & Nephew to thrive in the future.”

—WE (November 4, 2011)

company

Source: Smith & Nephew* On constant currency basis

Smith & Nephew 3Q11Sales

($ in millions)%

Change*

Total Sales $1,032.0 5.0%

Ortho/Trauma $548.0 3.00%

Endoscopy $226.0 7.0%

Advanced Wound Management $258.0 5.0%

Smith & Nephew


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201121Wright Medical 3Q: Ailing, Taking Medi-cine TABLE

Wright Medical Group, Inc.’s third quarter’s sales declined 3% to

$118.2 million. The company also announced it was reducing its revenue guidance by $12 million to $24 million for the entire year.

It was new CEO and President Robert Palmisano’s first opportunity to address Wall Street analysts during his first investor call on November 1.

On a reported basis, hips, knees and biologics declined 2.3%, 7.9% and 15.5%, respectively. The one bright spot was Extremities , growing by 7.5%

New CEO Meets Wall Street

Palmisano said, “We are clearly facing some challenges, which are reflected in our third quarter results and our outlook for the remainder of the year. However, Wright Medical is a company with great promise. We have excellent products and technologies across our orthopaedic businesses, and we are the recognized leader in the foot and ankle market. In addition, we have recently taken many positive steps to better posi-tion the company for success, including strengthening our compliance program and implementing a plan to reduce

o p e r a t i o n a l costs.

“My top pri-orities will be to continue building on this progress and focusing on areas where we can win,

including growing our foot and ankle business above market rates, running a much more focused and efficient recon business, and improving our bal-ance sheet to increase cash generation,” added Palmisano.

Palmisano addressed the reduction in revenue guidance by saying, “In reset-ting our guidance, we took into account the factors that are expected to affect our business for the remainder of the year, including procedure softness globally, as well as challenges associat-ed with implementing enhancements to our compliance processes and distribu-

tor transitions. I am confident that we will be able to capitalize on the market opportunities and work towards build-ing a leading global orthopaedic orga-nization.”

The company reported a net loss of $16 million in the quarter versus a profit of $4.7 million a year ago. Net income for the quarter included about $36.4 mil-lion in charges for assumed liability for device claims, restructuring plans, deferred prosecution agreement and other items.

BMO Capital Market Analyst Joanne Wuensch said she suspects the quar-ter and lowered guidance is a, “kitchen sink move by new management, and that this is a team that can make heads or tails of this mess.” She added the fer-vor that arrived with Bob Palmisano is “warranted, but it may take longer to see the results investors are expecting.”


Source: Wright Medical Group, Inc.

Wright Medical Group, Inc. 3Q11

Sales($ in millions)

% Change

Total Reported Sales $118.1 down 2.9%

Hips $39.0 down 2.3%

Extremities $32.3 7.5%

Knees $27.2 down 7.9%

Biologics $16.6 down 15.5

Other $2.9 22.4

Wikimedia Commons and U.S. Navy photo by Mass Communication Specialist 1st Class Carmichael Yepez


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201122NuVasive 3Q11: Noisy and Upward

A lawsuit with Medtronic, an acqui-sition of a monitoring technol-

ogy and nearly doubling the company’s outstanding number of shares from 70 million to 120 million highlighted the third quarter for NuVasive, Inc.

Revenue Up 10.5%

The company also reported a 10.5% increase in revenue to reach $132.9 mil-lion. Due to higher operating expenses attributed to litigation liabilities and additional costs associated with high-er revenue and infrastructure expan-sion, the company reported a net loss of $67.6 million for the quarter. Cash, cash equivalents, and short- and long-term marketable securities were $418.9 million at September 30, 2011.

Alex Lukianov, Chairman and Chief Executive Officer, said, “Our financial performance in the third quarter of

2011 attests to exceptional execution by the NuVasive team. In the face of an extremely challenging spine market, we delivered industry leading growth and executed a strategic transaction that will enhance the penetration of XLIF and NeuroVision for years to come. Our Impulse Monitoring acquisition increases our Intra-Operative Monitor-ing platform, allowing us to offer sur-geons and hospitals complete proce-dural solutions in all areas of spine…We will continue to remain laser focused on pushing toward our next milestone of being a $1 billion compa-ny with increasing profitability to serve the needs of spine surgery patients.”

Noisy Quarter

BMO Capital Markets Analyst Joanne Wuensch said this was, “a VERY noisy quarter for NuVasive, after a Medtronic patent loss, weak European revenue, delayed FDA products, and the clos-ing of a significant acquisition (Impulse Monitoring). Despite this, the com-pany’s revenue increased 11%, taking

market share, in a spine market that is noted as stable (or flat to slightly down). Management continues to drive for above market growth rates and a goal, longer term, of at least 15% top-line growth heading toward $1 billion in revenue and 20% operating margins.”

The Spine Journal Biologic Backlash

Wuensch said management told ana-lysts that biologics sales were not as robust as expected in the wake of The Spine Journal issue on Medtronic’s Infuse and a backlash on biologic prod-ucts, in general.

According to Wuensch, management believes that the spine landscape is sta-bilizing, as surgeons learn to navigate the environment and could return to mid-single-digit growth. The surgeon community continues to work through the restrictive guidelines on spine sur-gery. Citing a win over the State of Flor-ida Medicare Board, a case where the company immediately engaged the sur-geon community to request reversal of the non-coverage decision, the changes recommended by AANS were for the most part accepted, insuring patient access to appropriate care.

NuVasive, according to Jefferies Analyst Raj Denhoy, is far and away the fastest growing spine company and continues to take significant share, even in the face of numerous competitive launch-es. “While the market is still tough, the trend toward minimally invasive surgery and the dislocation among the larger companies are both working in NuVasive’s favor,” said Denhoy.

Onward and upward, as they like to say at NuVasive, can be noisy.

—WE (November 1, 2011)NuVasive Headquarters/NuVasive, Inc.


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201123Orthofix Beats Market and Expectations in 3Q11 TABLE

Orthofix International NV set a record for quarterly revenue in the

third quarter. Reported sales rose 4% to $144.7 million while beating revenue and earnings consensus. Currency con-tributed 2.6% to total sales.

Flat Spine

Sales performance included an 8% increase in implants and biologics rev-enue. The stimulation products used in spine applications decreased 8%. However, the company reported that

stimulation sales were up sequentially over the second quarter of 2011. Man-agement told analysts on October 27 that the year-over-year decrease in total spine sales was primarily a result of slowing industry-wide surgical proce-dures and organizational changes with-in their sales force.

Orthopedics on the Rise

Orthopedic product sales rose 16%. The increase was led by the company’s hardware platform and the increased use of Trinity Evolution in orthopedic applications but was partially offset by the reduction in stimulation products used in long-bone applications.

President and CEO Robert Vaters, commented, “We continue to deliver strong profitability and top-line growth amidst industry headwinds. At the same time we are upgrading talent and focusing our pipeline invest-

ments. I expect these improvements to continue as we resolve our pending legal matters and increase our invest-ment in new products.”

Mizuho Securities analyst Mike Matson said Orthofix is growing well above the spine market which he estimates declined by 3% on a constant currency basis during the quarter. Matson thinks the company can continue to outpace the market given its small size, new products (deformity, MIS, and PEEK spacers), and geographic expansion.

Jefferies analyst Raj Denhoy expects Orthofix’s revenue to grow in the mids-ingle-digits over the next couple years,

due to broad market challenges (pric-ing, volumes, reimbursement, etc.) coupled with headwinds in spine stim-ulation.


Source: Orthofix International NV

Orthofix Internatonal NV 3Q11

Sales($ in millions)

% Change

Total Reported Sales $144.7 4.0%

Spine Stim $39.7 down 8%

Implants/Biologics $36.8 8.0%

Total Spine $76.5 down 1%

Orthopedic $40.8 16.0%

Sports Medicine $25.6 8.0%

Wikimedia Commonsand Orthofix International NV

Advertisement

http://www.edenspine.com


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201124Zimmer’s 3rd Quarter- Steady Growth, Wait-ing for Patients

Zimmer Holdings, Inc. reported a 7% rise in sales to $1.031 billion

for the third quarter of 2011.

Hips led the way, rising 10% to $315 million. Knee sales reached $417 mil-lion, rising 3%. Spine lagged, dropping 2% to $55 million. Extremities and Trauma rose 7% and 19% respectively, all on a reported basis. The company’s reconstructive sales division reported a 6% increase in sales.

Analysts summarized the quarter with phrases like, “decent given the environ-ment” and “in-line with expectations”. Analysts also noted, given Zimmer’s results, the anticipated recovery of the orthopedic market will not take place in the second half of 2011.

Ortho Market

Based on actual results from Biomet, DePuy, Stryker and Zimmer, and esti-mates for the other companies, Mike Matson of Mizuho Securities, estimate that on a constant currency basis, global recon growth was 1% in the third quar-ter, up slightly from 0% in the second

quarter. He estimates that, on a constant cur-rency basis, global knee growth was 0% and global hip growth was 3% during the quarter.

Raj Denhoy of Jeffer-ies & Co. wrote that the orthopedic markets “remain anemic.” He noted that Zimmer’s U.S. recon businesses, which represent 40%

of sales, posted negative growth. Out-side the U.S., the company posted bet-ter growth owing to its market devel-opment efforts. “The company has all but written off 2011 with hopes pinned on a resumption of growth back to the mid-single digits,” wrote Denhoy. In the interim, as it waits for the turn, rather than pursue more aggressive strate-gic initiatives, Denhoy says Zimmer appears content with continued invest-ment in its selling infrastructure and supporting earnings through aggressive share buybacks.

Dvorak: “Procedures Will Return”

Zimmer’s President and CEO, Dave Dvorak told analysts during a confer-ence call on October 28, that demo-graphics dictate that customers will be back when they stop fearing losing their jobs.

During a question and answer session, Dvorak said, “These procedures will come back. And I think that people are just being pretty careful across the industry at projecting when there’s going to be a pickup in those procedure rates. But we know those cases are out there.

Dvorak continued, “You even saw a bit of an uptick on the hips side sequen-tially from Q2 to Q3 of this year. And I think that’s a sign that those procedures are still out there. I mean, the economy didn’t get healthier. Consumer con-fidence didn’t improve, but the need that those patients have broke through that barrier, and we saw a little bit of on uptick. I think the same thing will hap-pen in knees, and it’s difficult to predict which quarter it will begin to occur. But those patients are still out there.”

—WE (October 28, 2011)

Source: Zimmer Holdings, Inc.

Zimmer 3Q11Sales

($ in millions)% Change

Total Reported Sales $1,031 7.0%

Reconstructive $768 6.0%

Knees $417 3.0%

Hips $315 10.0%

Extremities $36 7.0%

Spine $55 down 2%

Trauma $69 19.0%

Hospital Waiting Room/Wikimedia.org



Whistleblower Costs DFine $2.39 Million for Kickbacks

A whistleblower has struck San Jose, California-based DFine Inc.

The U.S. Department of Justice (DOJ) announced on October 26 that DFine Inc. has agreed to pay $2.39 million to resolve allegations under the False Claims Act that the company paid kick-backs to “induce physicians to use cer-tain of the company’s devices.”

The government said DFine paid physicians up to $500 per patient to participate in customer surveys known as User Preference Evaluations (UPE). Each UPE survey required use of a new DFine device in a patient. Thus this was an “illegal kickback to induce [physicians] to use the company’s vertebral augmen-tation devices.”

The government alleges that DFine pro-vided improper remuneration in the form of “travel expenses, lavish dinners, entertainment and promotional speak-er fees” to doctors located in Chicago

and Little Rock, Arkansas. The govern-ment further alleges that DFine “solic-ited physicians to convert their busi-ness from a competitor’s product and/or persuade the physicians to continue using DFine products.”

Integra Introduces New Surgeon Lights

Surgeons havta, gotta see what they are doing. Respond-ing to that imperative, Integra LifeSciences Holdings

Corp. has introduced a new surgical headlight system that, according to Integra, is designed to deliver the cool bright-ness and color needed for visibility along with increased mobility in the operating room.

Called the LED Headlight System, it has received 510(k) clearance from the FDA and is being featured at the A m e r i c a n

College of Surgeons Annual Clinical Conference in San Francisco.

Company officials describe the system as one that provides vibrant color rendition that maximizes visualization of crit-ical anatomy across a broad range of surgical procedures. It’s 25,000+ hour lamp life ensures a dramatically longer life than the more traditional xenon surgical lighting sys-tems, which have a lamp life of approximately 1,000 hours. They note that the LED Headlight System also provides greater mobility with either a lightweight 20-foot power cord (that eliminates the clutter of floor stands and fiber optic cables), or a light weight battery option that allows surgeons untethered mobility within the operating room.

“We expect surgeons will welcome the same low cost of ownership, cool output and extremely long life that’s helping LEDs become the standard in other markets. In addition, this self-contained headlight does not require fiber optic cords, introducing surgeons to a new level of independence, by allowing them to move more freely about the operating room,” said Dan Reuvers, president, Instruments.

—BY (October 28, 2011)

Source: Wikimedia Commons and ESA/Hubble and NASA

legal

Source: Department of Justice and DFine Inc


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201126“Decisions about devices used to treat serious spinal conditions should be based on the best interests of the patient, not on whether the manufac-turer is going to pay a kickback,” said Tony West, Assistant Attorney General for the Justice Department’s Civil Divi-sion. “These sorts of improper finan-cial incentives not only undermine the integrity of medical decisions, they also waste taxpayer funds and are unfair to competitors who are trying to play by the rules.”

This action was initiated by the filing of a qui tam, or whistleblower, action under the False Claims Act by Brian Eberhard. The act permits a whistle-blower to file a lawsuit on behalf of the government and share in any recov-ery. In this case Eberhard will receive approximately $250,000.

Also as part of the settlement, DFine has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Ser-vices. That agreement provides for pro-cedures and reviews to be put in place to “avoid and promptly detect conduct similar to that which allegedly gave rise to this matter,” stated the government announcement.

The Justice Department has used the False Claims Act to recover more than $5.9 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Depart-ment’s total recoveries in False Claims Act cases since January 2009 exceed $7.8 billion.

The company issued the following statement regarding the settlement.

“DFine fully cooperated with the inves-tigation and continues to deny all of

DOJ’s unproven allegations. The terms of the agreement specifically state that DFine and its employees admit no

wrongdoing, liability or illegal activity. The decision to settle prior to complet-ing the full investigation was a very dif-

Advertisement


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201127ficult one, but one we felt was best for the company based upon the significant disruption and associated costs to con-tinue the investigation, as well as the uncertainty regarding its duration.


September 2011 FDA Approval Summary

A reader recently asked us to give a monthly update of PMAs (pre-

market applications) or supplemental approvals that were issued by the FDA during the past month.

In September, the FDA approved one original and 81 supplemental applica-tions.

The original approval was for Plu-romed, Inc’s LeGoo, a device indicated for temporary endovascular occlusion of blood vessels below the neck up to 4 mm in diameter.

There were two orthopedic related sup-plemental approvals.

DePuy’s Ceramic Hip

The first was for DePuy Orthopaedics, Inc’s Ceramax Ceramic Total Hip Sys-tem.

Supplemental approval was for the addition of the Trio-Lock BPS (Bone Pre-serving Hip Stem) and 28 mm ceramic femoral heads with a 12/14 taper and +1.5 mm, +5 mm, and 8.5 mm offset as compatible modular components to the system, and minor labeling changes to the device package insert and surgical technique.

The device, as modified, will be mar-keted under the trade name DePuy

Ceramax® Ceramic Total Hip System and is indicated for noncemented use in skeletally mature individuals undergo-ing primary total hip replacement sur-gery for rehabilitation of hips damaged as a result of noninflammatory degener-ative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and post traumatic arthritis.

EBI’s Bone Healing System

The second was for EBI, LLC’s EBI Bone Healing System.

Supplemental approval was for the replacement of an analog electrical iso-lation tester with a digital electronic iso-lation tester, and addition of a manual hand-soldering process as an alterna-tive to the existing automatic soldering process.

PMA/Supplemental Approval Sum-mary

A summary of the FDA’s September PMA/Supplemental activity was as fol-lows:

•Total number of PMA Originalsunder review - 94. Half are active and half are on hold. Three appli-cations have been under consider-ation more than 180 days.

•TotalnumberofPMASupplementsunder review - 585. Of those, 430 are active and 155 are on hold. Eleven are older than 180 days.

•For theyear,81PMAsorSupple-ments have been approved and 0 have been denied. The average number of days to a final decision from the receipt of the application was 118 days.

The FDA received two new PMA and 69 Supplements applications during the month.

To view the FDA Web site, click here: http://www.fda.gov/MedicalDevic-es/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm277367.htm

—WE (October 27, 2011)

RRY Publications

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm277367.htm



New Options for Dam-aged Ankles

Arthrosurface, Inc., a Franklin, Mas-sachusetts company engaged in

the development of joint resurfacing systems. In Europe, the company has launched a resurfacing system for dam-age to the ankle. Named the HemiCap Talus Resurfacing System, the process has been clinically evaluated by foot and ankle surgeons throughout Europe for the past four years.

Arthrosurface officials report that over 100 patients who had received their implants, when asked, reported a high level of satisfaction. According to Dr. C.

Niek van Dijk, Department of Orthopae-dic Surgery, University of Amsterdam, “Metallic implantation with the Hemi-

CAP® system offers a promising new solu-tion for those patients who have failed their primary treatment. For these young and active patients it is important to restore the damaged area in order to protect the underlying bone and prevent further cyst formation. I am very encouraged by our clinical results over the last four years.”

Focal defects of the talar dome are often caused by trauma and result in deep,

extremities

BeamMed

New Tool for Early OA Assess-ment

Israel-based BeamMed has announced that its Sunlight MiniOmni bone sonometer has been cleared by the FDA

and can now be marketed in the U.S. Recently, the Sun-light MiniOmni also received a medical device license from Health Canada. The Sunlight MiniOmni device received CE mark clearance in October 2010. To date, BeamMed has sold hundreds of Sunlight MiniOmni systems world-wide.

“Now that the North American market has been opened to us, we expect to see strong sales of the Sunlight MiniOmni, similar to the success we are achieving in Europe, Asia and the Far East,” said Mr. Tal Marom, CEO, at BeamMed, in the November 3, 2011 news release.

As indicated by the company, the Sunlight MiniOmni bone sonometer provides an exceptionally affordable, pro-fessional solution for early assessment of osteoporosis. It enables reliable, accurate, non-invasive and safe monitor-ing of bone density at the point of care. Its small size and weight, intuitive ease of use, and convenient USB-port con-

nectivity to Windows-based PCs and laptops make it ideal for use in any physician office or medical clinic, pharma-cy, annual checkup center or other retail venue. Sunlight MiniOmni is based on the same proprietary quantitative ultrasound technology that has been proven in thousands of Sunlight Omnisense installations worldwide.

—EH (November 3, 2011)

Wikimedia Commons and Nevit Dilmen


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201129cup-shaped lesions. This incongruity of the joint surface and resulting cartilage damage often alters contact stresses in the ankle joint and can lead to the devel-opment of painful cysts deep within the bone. It is these cysts and fluid pressure on areas of exposed bone that causes significant pain and debilitation.

Dr. Ned Amendola, professor of Ortho-paedics and director of Sports Medi-cine at the University of Iowa, notes that, “The HemiCAP® Talus Resurfac-ing System allows surgeons to restore the damaged surface of the talar dome by reproducing three surfaces with one implant, namely the dome, ridge and medial wall. In our study we showed that the HemiCAP® Talus System re-approximates the native geometry of the talar dome providing a load sharing surface to help protect the remaining rim of good cartilage.”

Previous alternatives available to patients after failing their primary treatment were to opt for total ankle replacements or ankle fusions. An ankle replacement removes a significant amount of bone and has a higher risk of failure than other joint replacements and fusion permanently eliminates the movement of the ankle joint. The Hemi-CAP® Talus implant, when successful, gives patients another option that is less invasive, preserves the joint and allows for normal activity.

The Arthrosurface HemiCAP® Talus System offers over 150 different sizes and shapes to effectively cover the dam-aged area and match the contours of the patients’ joint surface.


JBJS: Timing of Lum-bar Surgery

Don’t delay…call the number on your screen now! Well, just don’t

delay treatment…A new study in the Journal of Bone and Joint Surgery (JBJS) has found that patients with herniated lumbar disc symptoms were signifi-cantly worse if the patients had symp-toms for more than six months prior to treatment, compared to those who had symptoms for six months or less.

“Patients often ask their physicians whether the duration of their symp-toms will affect their potential for a full recovery, and the goal of our study was to address this question,” said orthope-dic surgeon Jeffrey A. Rihn, M.D., in the October 25, 2011 news release.

“According to our study and generally speaking, patients who had symptoms for more than six months had less

improvement in pain, function, general health, work status, and patient satis-faction,” added Dr. Rihn.

The study authors observed 1,192 patients enrolled in the Spine Patient Outcomes Research Trial (SPORT), which was conducted at 13 multidis-ciplinary spinal practices in 11 states. The patients were older than age 18 and suffered from various symptoms of lumbar disc herniation. Patients were assigned to undergo either operative treatment—lumbar discectomy—or nonoperative treatment—such as phys-ical therapy, education, a nonsteroidal anti-inflammatory drug, and/or coun-seling with home exercise instruction.

The researchers analyzed the outcomes of the operative and nonoperative treat-ments. They compared the treatment outcomes of the 927 patients who had symptoms for six months or less to those of the 265 patients who had symp-toms for more than six months prior to enrolling in the study. At all follow-up intervals, outcomes were significantly worse in patients who had symptoms

spine

Wikimedia Commons and A E Francis


VOLUME 7, ISSUE 35 | NOVEMBER 8, 201130for more than six months prior to treat-ment than in those who had symptoms for six months or less.

Dr. Rihn told OTW, “I think there were several interesting findings from this study. First, we found that the dura-tion of symptoms from a symptomatic lumbar disc herniation seems to have a significant effect on the outcome of treatment, whether it be nonoperative or operative treatment, with those hav-ing greater than six months of treatment gaining less benefit over their baseline status compared to those with less than six months of symptoms. Also, how-ever, it is important to note that even patients with greater than six months of treatment still get significant improve-ment with surgery, and that surgery still has a significant advantage over nonop-erative treatment in those patients with a longer duration of symptoms.”

—EH (October 31, 2011)

Spineology Launches own Fusion Device

With FDA clearance firmly in hand, Spineology, of Saint Paul,

Minnesota, is launching its first lum-bar interbody fusion device into the market. Called the Rampart Interbody Fusion System, the product has been under development for more than a year, according to Dan McPhillips, vice-president of marketing.

“Rampart is a great synergistic fit for our growing product line.” He said, add-ing that the Rampart System includes a variety of configurations, length and heights, to provide surgeons with a variety of options to help them meet the needs of their patients. The system is configured with implantation equip-ment that is designed to assist the sur-geon in positioning the implant within the disc space.

McPhillips told OTW that Spineology was founded in 1996 by Dr. Stephen Kuslich. Dr. Kuslich was a pioneer in minimally invasive spine surgery and was instrumental in the development of numerous spinal implants, including the BAK spine cage (co-invented with Dr. George Bagby of the Mayo Clinic in Rochester, Minnesota) and Spineology’s flagship product, OptiMesh. According to company officials, the firm focuses on surgical techniques that conserve spinal bone, ligament and muscle tissue while increasing pro-cedural efficiency. The products reduce the invasiveness of spine surgery for patients, aid the surgeon in overcoming the hurdles of minimally invasive sur-gery, and try to minimize the burden of healthcare expense.


Advertisement Spineology/Morguefile/RRY Photo Creation

http://www.lifelinktb.org



K2M Launches RA-VINE, ALEUTIAN Sys-tems

New Tool Alert! K2M, Inc. has launched the RAVINE Lateral

Access System along with the ALEU-TIAN Lateral Interbody System at the 2011 Society for Minimally Invasive Spine Surgery (SMISS) Annual Meeting in Las Vegas.

RAVINE provides a dual flat blade platform for a less invasive muscle split-ting transpsoas approach. The system offers rigid fix-ation to the spine and the versatility of both a third and fourth blade intraop-erative option. It repre-sents an innovative design departure from the tubular retractors, while providing tremendous adaptability to both patient anatomy and surgeon technique.

In the October 20, 2011 news release, Dr. Pierce Nunley, an orthopedic sur-geon at The Spine Institute of Louisiana, stated, “The RAVINE retractor provides an innovative anatomical deployment and retraction that was designed from the outset to be a transpsoas retractor. This decreases the retraction of tissue, while providing the sur-geon with secure access to the disc space.”

“Following our initial debut of RAVINE at the

2010 NASS, we conducted global train-ing and infrastructure expansion to execute the global launch,” added Eric Major, K2M’s President and CEO. “This next generation product reaffirms our commitment to being a pioneer in the global spine market and a leader in the minimally invasive market.”

Major told OTW, “In my opinion, there are three things that make the RAVINE

Retractor a best in class product: Access - Less tissue disruption for access to the spine; Fixation - Fixation to the spine allowing for predictable stability during the procedure; Visualization - Excellent visualization of the spine during the surgery.”

—EH (October 27, 2011)

K2M, Inc.

http://www.pearldiverinc.com



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