30
VOLUME 8, ISSUE 34 | OCTOBER 23, 2012 1-888-749-2153 | www.ryortho.com week in review breaking news 4 The Right Trial – Coflex ® The VBs have done it again. An- thony, John and Marc led the way in motion preservation. This week they set the pace for the industry with an ambitious and complex PMA study—375,000 clinical and radio- graphic data points and economic data. This study was about much more than an implant. It was about comparative effectiveness. It was about the future. 8 The Truth Behind Ration- ing, Overcrowding and Shortages ♦ Predictions of health care rationing, emergency room overcrowding and physician shortages under Obamacare are made by critics of the new law. Supporters say other- wise. What’s the nonpartisan view? ProCon.org dug in with a 128-page review of 62 questions about the law. We highlight three of great interest to orthopedic surgeons. 13 Medicare Clawing Back Reimbursements! ...Key to Happiness for Orthopedists?...Hospital Success Drives Shoulder Sur- gery Value…Roy Sanders, M.D. Named Health Care Hero… 20 Bone Regeneration Focus of New Firm .......................................... Stryker’s New CEO Lowers Expecta- tions ............................................................ J&J’s Ortho’s 3Q Debut ............................................................ Wright In the Clear ............................................................ Ankle Replacements–Growing Step- child of Hips & Knees ............................................................ McCollum Takes Over Orthofix Spine Business ............................................................ Two New FDA Rulings Expand Integ- ra’s Product Offerings For all news that is ortho, read on. 16 Pellegrini Battles Padgett Over DVT Anticoagulants ♦ “Bal- ance,” argues Vincent Pellegrini. “I accept less effective prevention of venographic disease to avoid bleeding complications, but I still want effec- tive prevention of clinical events.” “The biggest issue now is safety,” says Doug Padgett. “And there are better and safer alternatives to chemoprophylaxis.”

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VOLUME 8, ISSUE 34 | OCTOBER 23, 2012

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

week in review

breaking news

4 The Right Trial – Coflex® ♦ The VBs have done it again. An-thony, John and Marc led the way

in motion preservation. This week they set the pace for the industry with an ambitious and complex PMA study—375,000 clinical and radio-graphic data points and economic data. This study was about much more than an implant. It was about comparative effectiveness. It was about the future.

8 The Truth Behind Ration-ing, Overcrowding and Shortages ♦ Predictions of

health care rationing, emergency room overcrowding and physician shortages under Obamacare are made by critics of the new law. Supporters say other-wise. What’s the nonpartisan view? ProCon.org dug in with a 128-page review of 62 questions about the law. We highlight three of great interest to orthopedic surgeons.

13 Medicare Clawing Back Re imbursements ! ...Key to Happiness

for Orthopedists?...Hospital Success Drives Shoulder Sur-gery Value…Roy Sanders, M.D. Named Health Care Hero…

20 Bone Regeneration Focus of New Firm..........................................

Stryker’s New CEO Lowers Expecta-tions............................................................J&J’s Ortho’s 3Q Debut............................................................Wright In the Clear............................................................Ankle Replacements–Growing Step-child of Hips & Knees............................................................McCollum Takes Over Orthofix Spine Business............................................................Two New FDA Rulings Expand Integ-ra’s Product Offerings

For all news that is ortho, read on.

16 Pellegrini Battles Padgett Over DVT Anticoagulants ♦ “Bal-

ance,” argues Vincent Pellegrini. “I accept less effective prevention of venographic disease to avoid bleeding complications, but I still want effec-tive prevention of clinical events.” “The biggest issue now is safety,” says Doug Padgett. “And there are better and safer alternatives to chemoprophylaxis.”

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VOLUME 8, ISSUE 34 | OCTOBER 23, 20122

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

THIS WEEK: After a strong summer and early fall, traders took profits last week. October is always a spooky time for equities—ever since the 1987 crash. Last week’s dip has more than a few traders worried. One inconvenient factoid that someone brought up recently. The 1987 crash was preceded by U.S. shelling of Iranian oil fields and a resulting oil disruption. Too coincidental with today’s mid-east saber rattling.

RANKLAST WEEK

COMPANYTTM OPMARGIN

30-DAYPRICE CHANGE

COMMENT

1 1Globus Medical

30.06% 0.89%Still #1 but harder to justify as GMED’s comparative

valuation becomes richer and richer.

2 2 Medtronic 28.65 (1.94)This is a leaner, more interesting Medtronic Spine than

five years ago. Good stuff coming.

3 7Symmetry Medical

5.63 (6.74)Inks key distribution deal with AMT to distribute all of

SMA’s products to 400 hospitals in Canada.

4 5 Conmed 10.39 (3.53)Announcing Q3 this week and most analysts are

expecting 20% earnings growth on 6.5% sales growth.

5 NRJohnson & Johnson

25.58 4.75Buyers were seriously buying JNJ this past month

(3.40% current yield) and that usually is a sign of a nervous market.

6 8 Zimmer 26.37 (6.63)Analysts are pretty optimistic about Big Blue’s earnings

this quarter—8.7% growth rate is consensus on flat sales growth.

7 10 Stryker 23.68 (5.81)With the purchase of Israeli technology company

Surpass, SYK beefs up its neurovascular business. Up 3 spots.

8 3 ArthroCare (0.80) (2.46)Very liquid company, but with comparatively modest sales and earnings growth. Should be on someone’s

M&A short list.

9 9Smith & Nephew

21.36 (7.01)It’s tough to see the catalyst with SNN. Flat earnings

on down sales. That’s what most analysts expect this quarter.

10 4 Orthofix 16.23 (9.46)Wall Street’s losing confidence in OFIX. Probably a

mistake, but this is no time to fight the tape.

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VOLUME 8, ISSUE 34 | OCTOBER 23, 20123

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

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

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)

LOWEST PRICE TO SALES RATIO (TTM) HIGHEST PRICE TO SALES RATIO (TTM)

COMPANY SYMBOL PRICE MKT CAP 30-DAY CHG

1 TiGenix TIG.BR $1.12 $103 58.72%2 TranS1 TSON $3.11 $85 25.91%3 Alphatec Holdings ATEC $1.75 $157 5.42%4 Johnson & Johnson JNJ $71.86 $198,121 4.75%5 Globus Medical GMED $16.91 $1,530 0.89%6 RTI Biologics Inc RTIX $4.10 $229 0.00%7 CryoLife CRY $5.69 $156 -1.22%8 Medtronic MDT $42.00 $42,846 -1.94%9 ArthroCare ARTC $30.95 $858 -2.46%

10 Conmed CNMD $27.35 $777 -3.53%

COMPANY SYMBOL PRICE MKT CAP P/E

1 Zimmer Holdings ZMH $62.69 $10,952 12.392 Medtronic MDT $42.00 $42,846 12.463 Stryker SYK $52.64 $20,027 13.294 Orthofix OFIX $40.01 $759 13.665 Johnson & Johnson JNJ $71.86 $198,121 14.23

COMPANY SYMBOL PRICE MKT CAP PEG

1 Orthofix OFIX $40.01 $759 0.872 ArthroCare ARTC $30.95 $858 1.003 Globus Medical GMED $16.91 $1,530 1.234 Zimmer Holdings ZMH $62.69 $10,952 1.285 Exactech EXAC $15.14 $201 1.34

COMPANY SYMBOL PRICE MKT CAP PSR

1 Alphatec Holdings ATEC $1.75 $157 0.802 Symmetry Medical SMA $8.99 $329 0.923 Exactech EXAC $15.14 $201 0.984 Conmed CNMD $27.35 $777 1.075 NuVasive NUVA $13.36 $581 1.07

COMPANY SYMBOL PRICE MKT CAP 30-DAY CHG

1 NuVasive NUVA $13.36 $581 -38.06%2 MAKO Surgical MAKO $15.05 $642 -19.99%3 Bacterin Intl Holdings BONE $1.27 $54 -16.99%4 Exactech EXAC $15.14 $201 -12.03%5 Orthofix OFIX $40.01 $759 -9.46%6 Integra LifeSciences IART $37.69 $1,019 -9.24%7 Tornier N.V. TRNX $17.82 $708 -7.72%8 Smith & Nephew SNN $51.77 $9,328 -7.01%9 Symmetry Medical SMA $8.99 $329 -6.74%

10 Zimmer Holdings ZMH $62.69 $10,952 -6.63%

COMPANY SYMBOL PRICE MKT CAP P/E

1 Wright Medical WMGI $20.47 $811 78.732 Symmetry Medical SMA $8.99 $329 52.883 NuVasive NUVA $13.36 $581 40.484 RTI Biologics Inc RTIX $4.10 $229 22.785 ArthroCare ARTC $30.95 $858 18.99

COMPANY SYMBOL PRICE MKT CAP PEG

1 Wright Medical WMGI $20.47 $811 7.642 CryoLife CRY $5.69 $156 4.743 Symmetry Medical SMA $8.99 $329 4.414 NuVasive NUVA $13.36 $581 3.845 Smith & Nephew SNN $51.77 $9,328 3.68

COMPANY SYMBOL PRICE MKT CAP PSR

1 TiGenix TIG.BR $1.12 $103 89.592 MiMedx Group MDXG $2.70 $231 29.733 MAKO Surgical MAKO $15.05 $642 7.604 Globus Medical GMED $16.91 $1,530 4.615 TranS1 TSON $3.11 $85 4.43

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VOLUME 8, ISSUE 34 | OCTOBER 23, 20124The Right Trial – Coflex®

By Robin Young

Since 2008 the FDA has received 18,000 510(k) submissions and

193 PMA (premarket approval) sub-missions—for all medical devices. It is such an article of faith that orthopedics is based on 510(k) submissions that the rare PMA is greeted with wonderment often reserved for obscure bird species.

If it were a rare bird, the ortho PMA would be nearly invisible (1% of all birds) but when sighted, would look like a feathered bull dog and exhibit unfathomably expensive eating habits. The PMA bird literally gobbles up thou-sand dollar bills.

But in the past 30 days the industry has been graced with sightings of two PMAs—Globus’ SECURE-C Cervical Artificial Disc and Paradigm Spine’s Coflex.

Of the two, Paradigm’s Coflex may well be the most unique because, in many ways, it was the most ambitious and could well influence the broader payer and provider formularies going for-ward.

No surprise, the architects of the Coflex PMA are none other than the Viscogli-osi brothers (Marc, John and Anthony). These three gentlemen have been at the forefront of orthopedic trends for the better part of the past quarter century. They are probably most famous for hav-ing defined the motion preservation future of spine care and for also putting the first dollars behind this now stan-dard technology. Before JNJ, Synthes, Stryker, Medtronic. Before everyone.

Could the Coflex trial have the same impact on spine care that the VB’s ini-tiatives in motion preservation? We think so.

Consider that:1. It is the first prospective, level 1

PMA spine study which collect-ed healthcare economic data in addition to clinical, radiographic and safety data for spinal steno-sis.

2. It achieved a 95% follow up through two years—the HIGH-EST for any PMA approved device in spine.

3. It used lumbar pedicle screw fusion following surgical decom-pression—the bread and butter of the spine industry—as the control.

4. It included a significant number of Medicare-aged patients.

Then, the outcomes were this good:1. Coflex saved an average of $5,000

-$8,700 per case when compared to pedicle screw fusion for spinal stenosis.

2. Coflex patients spent 40% less time in the hospital compared to fusion patients (1.90 days vs. 3.19 days)

3. Coflex surgeries were 36% faster than fusion (98 minutes vs. 153 minutes).

4. Motion was preserved. At two years follow up, Coflex patients retained their pre-op range of motion and translation at the treated level. Fusion patients did not. By contrast, the fusion

Paradigm’s Coflex

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VOLUME 8, ISSUE 34 | OCTOBER 23, 20125patients reported a 62% motion reduction at the treated level.

5. Coflex patients maintained normal adjacent level motion. Fusion patients did not. The fusion patients experienced a 52% INCREASE in adjacent seg-ment range of motion.

6. And Coflex patients reported bet-ter outcomes to fusion at every time period.

Coflex

Coflex is a simple design—a single, U-shaped piece of metal (medical grade titanium alloy) which is placed (see the illustration) between the spinous pro-cesses. The “U” portion fits up against the anterior part of the spine and the two wings extend outward along both the superior and inferior spinous pro-cesses. In that position, Coflex decom-presses the segment while allowing for

motion both at the treated segment and at the adjacent levels.

It comes in five sizes: 8, 10, 12, 14 and 16mm. Stenosis patients in about 40 countries outside the United States (Europe, Middle East, Asia, Central and South America) have had Coflex avail-able for them since 2005.

It’s a simple product.

But Not a Simple Study

The first patient was treated in Octo-ber 2006 and enrollment continued until March 2010. Three hundred and eighty-four patients were enrolled con-sisting of up to 40 non-randomized “roll-in” patients and 344 randomized patients. Excluding 22 protocol viola-tors, 215 randomized Coflex patients

and 107 randomized control patients were enrolled. There were 21 investi-gational sites.

This study was a prospective, random-ized, multi-center, concurrently con-trolled clinical study.

The surgeons were blinded prior to patient randomization.

The patients were blinded until after surgery.

The control group was posterolateral fusion with autograft bone and pedi-cle screw fixation, following surgical decompression. The products used in the control were the ExpediumTM (Johnson and Johnson, Inc.) and the CD Horizon LegacyTM (Medtronic, Inc.). Paradigm’s Coflex

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VOLUME 8, ISSUE 34 | OCTOBER 23, 20126

An independent Data Safety Moni-toring Board (DSMB) evaluated all safety events on a quarterly basis dur-ing the course of the study to ensure patient safety was not compromised. All adverse events were independently reviewed and adjudicated by a Clinical Events Committee (CEC), with their decision binding on the study sponsor. All radiographs were analyzed by an independent core lab (Medical Metrics, Inc.).

All patients were re-examined at 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months postopera-tively.

Patients were evaluated for Oswestry Disability Index (ODI), Zurich Clau-dication Questionnaire (ZCQ), SF-12, back and leg pain (via visual analog scale (VAS)), and neurological assess-ment at preoperative visit and at all

postoperative visits. Radiographic eval-uation was performed at all time points. Adverse events and complications were recorded at all visits.

In all, there were 589 data points col-lected for each patient.

At the end of the study, the VBs had amassed:•55,000 patient completed case

report form pages•375,000 clinical and radiographic

data points•12,000patientX-rays.

And, of course, economic data for lum-bar pedicle screw fusion and Coflex.

The Conclusions

“At every assessment time period, the percentage of Coflex patients achiev-ing composite success was greater

than fusion, with the largest differ-ences occurring at week six and month three. Sensitivity analyses show that the Coflex device’s non-inferiority to fusion is not sensitive to missing data. In addi-tion, all components of overall success of the Coflex group are comparable to or better than the control group. At 24 months, 85.8% of Coflex patients com-pared with 76.7% of fusion patients experienced at least a 15 point reduc-tion in ODI.” – from the FDA’s report.

The average operating time in the fusion patients was 55.2 minutes greater than the Coflex patients. Average blood loss in fusion patients was 238.9 cc greater in the fusion patients than in Coflex patients. The average hospital length of stay was 1.29 days longer in the fusion patients.

Non-inferiority of the Coflex group compared to the control group was

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VOLUME 8, ISSUE 34 | OCTOBER 23, 20127

demonstrated for the Composite Clini-cal Success (CCS) at 24 months. The CCS at 24 months is determined by the ODI improvement compared to base-line, absence of secondary surgeries or epidural pain management and neu-rologic success. Patients in the Coflex group demonstrated an 81.9% CCS at 6 weeks which increased to 82.6% at 3 months and gradually fell to 66.2% at 24 months. Patients in the control group demonstrated 65.7% CCS at 6 weeks which rose gradually from 6 Weeks to 6 Months to 77.1%. CCS fell to 57.7% at 24 months. At every assessment time period, the percent-age of Coflex patients achieving CCS was greater than fusion, with the larg-est differences occurring at week 6 and month 3, demonstrating statistical significance at those time points. The final CCS at 24 months demonstrates numerical success that is 8.5% higher in the Coflex® group when compared to the fusion control.

And…Economic Data

The Coflex study was the first Level-1 study to quantify the cost differential based on prospective data comparing the current standard of care (postero-lateral fusion) to the new treatment. On average, Coflex saved $8,700 per case when compared to a fusion. Upon examination of the data, five aspects of the Coflex treatment created these cost differentials: shorter operating room time, faster patient recoveries, less blood loss, less narcotic usage and shorter hospital stays—while also pro-ducing faster and more sustained clini-cal success.

Said Marc Viscogliosi, Chairman and CEO of Paradigm Spine: “This study provides the evidence that insurance companies, surgeons and patients have been demanding. Insurance compa-nies, surgeons and patients finally have an alternative to fusion which, based on independent study data, has dem-onstrated that Coflex produces bet-ter outcomes, faster recover, preserves motion and may be performed on an outpatient basis. For patients, the abil-ity to walk without back pain and the progressive symptoms of stenosis is one of the most cherished functions of the aging population.”

“Better and Lower Cost”

Finally, Reginald Davis, M.D., the study’s principal investigator said, “This is the first time a new spinal technology is proven to be better and more effective than the historical gold standard and is still actually lower cost. I am excited to be able to provide Coflex to my patients without the need for fusion through a simple, motion preserving, and mini-mally invasive bone saving surgical technique.” ♦

Source: FDA SSED Report * Composite Clinical Success

Table 17: Posterior Probabilities of Success at 24 Months in Coflex Clinical Trial

Number and Percentage Achieving Month 24 CCS*Posterior Probability

of Non-InferiorityCoflex Fusion Control

N n % N n %

Month 24 204 135 66.2% 104 60 57.7% 0.999

The Endoskeleton® implants fea-ture Titan Spine’s nano surface technology that has been shown to produce a superior osteogenic response when compared to PEEK and smooth titanium*

*Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D., 2012, Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone, The Spine Journal, v. 12, p. 265-272.

Notice: One or more products are covered by patents

If all you see are interbody devices, you aren’t looking

closely enough

Osteoblasts

Please visit NASS booth #531 for a closer look

The Endoskeleton® implants fea-

If all you see are interbody devices, you aren’t looking

closely enough

THE LEADER IN SURFACE TECHNOLOGY

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VOLUME 8, ISSUE 34 | OCTOBER 23, 20128The Truth Behind Rationing, Overcrowding and Shortages By Walter Eisner

Will there be emergency room over-crowding, rationing and ortho-

pedic surgeon shortages as a result of the passage of the Affordable Care Act (ACA), known as Obamacare? What are the nonpartisan answers to these ques-tions?

ProCon.org, a non-profit nonpartisan group. recently compiled responses to these 3 and 59 other questions about the new law from legislators and health care experts.

The 128-page review titled “Obam-acare: A Nonpartisan Review of What It Is and What It Is Not” features 62 ques-tions of which 39 have clear yes or no answers while the other 23 are debated using sourced pro and con responses.

You can read the entire 128-page review here: http://www.procon.org/headline.php?headlineID=005126 orhttp://healthcarereform.procon.org/sourcefiles/obamacare-nonpartisan-review.pdf

We picked out the pros and cons of the three questions asked above.

Emergency Room Overcrowding?

Won’t happen, say Cathy Bradley, Ph.D., and Sabina Gandhi, Ph.D., at the School of Medicine, Virginia Common-wealth University, and David Neumark, Ph.D., from the University of California at Irvine.

Following a February 2012 study, they write: “Increased access to care is intended to reduce the unnecessary use of services such as emergency depart-

ment visits and to achieve substantial cost savings.”

However, they admit there is little evi-dence for such claims.

So they looked at uninsured low-income adults enrolled in a community-based primary care program at Virginia Com-monwealth University Medical Center. For people continuously enrolled in the program, emergency department vis-its and inpatient admissions declined,

Wikimedia Commons and John Vachon/image manipulation RRY Publications LLC

Photo courtesy of procon.org

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VOLUME 8, ISSUE 34 | OCTOBER 23, 20129

while primary care visits increased dur-ing the study period and inpatient costs fell each year for this group.

“Over three years of enrollment, aver-age total costs per year per enrollee fell from $8,899 to $4,569—a savings of almost 50%. We conclude that previ-ously uninsured people may have fewer emergency department visits and lower costs after receiving coverage but that it may take several years of coverage for substantive health care savings to occur.”

John Goodman, Ph.D., President and CEO at the National Center for Policy Analysis, disagrees. In June 2010, he wrote: “More people are likely to turn to the emergency room for their health care and they are likely to do so more frequently under the new health reform legislation.”

He says emergency room costs will increase for two reasons: 1) about half the newly insured will enroll in Medicaid and Medicaid patients seek emergency room care more often than the unin-

sured, and 2) while the newly insured will try to increase their consumption of care, the absence of any program to cre-ate more providers will force patients to turn to emergency rooms as the outlet for increased demand.”

Lynn Massingale, M.D., Executive Chairman of TeamHealth, wrote this past June that the uninsured popula-tion has health care needs on reserve. He also says there is not a primary care practice excess in the country. “The odds are that newly insured individu-als will not be able to see primary care practitioners and instead will visit an emergency room.”

Patient volumes in the emergency room are increasing as hospitals close and patients are consolidated into fewer ERs. Adding in an aging population will increase patient volume.

Independent Patient Advisory Board (IPAB) Rationing?

There will be rationing according to Wesley Smith, Senior Fellow at the Dis-

covery Institute. In July 2012 he wrote: “IPAB’s unique ‘fast track’ authority divests Congress of discretion regarding the amount of money to be cut from Medicare once IPAB has submitted its ‘advice.’”

By January 15, 2014, IPAB must submit a proposal to Congress and the presi-dent which explains how Medicare will achieve its savings targets in the com-ing year. Congress has to introduce bills which also incorporate the board’s pro-posal the day they receive it. Congress cannot change or amend the report and all legislative committees must com-plete their evaluations by April 1st.

“If Congress does not pass the pro-posal or a substitute plan meeting the IPAB’s financial target before August 15, or if the president vetoes the proposal passed by Congress, the original IPAP recommendations automatically take effect,” wrote Smith.

This past July, Steven Ertelt, Founder and Editor of LifeNews.com, wrote that the Department of Health and Human Services (HHS) will be empowered to impose so-called “quality and efficien-cy” measures on health care provid-ers, based on recommendations by the IPAB, which is directed to force private health care spending below the rate of medical inflation.

“In many cases treatment that a doctor and patient deem needed or advisable to save that patient’s life or preserve or improve the patient’s health but which runs afoul of the imposed standards will be denied, even if the patient wants to pay for it,” wrote Ertelt.

The law denies seniors the choice of private-fee-for-service plans whose pre-miums are sufficient to provide unra-tioned care but which HHS disallows.

Andrew Huth

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201210

The law could therefore lead to elimi-nation of the only way that seniors will have to escape rationing—by letting them pay for their own care.

No way, writes Ira Byock, M.D., Direc-tor of Palliative Care at Dartmouth-Hitchcock Medical Center.

“Many of the people I care for are incur-ably ill and need expensive medical care to stay alive. They’ve heard politicians say ‘Obamacare’ will take away their choices, rob them of hope for living longer and cast their fate to ‘death pan-els’ of faceless bureaucrats. Fortunately, none of this is true.”

He argues the law aligns financial incentives with high-quality treatment through Accountable Care Organiza-tions (ACOs) and “transforms health-care by making local health systems—made up of doctors, hospitals, clinics,

laboratories and imaging facilities—responsible for the outcomes of care and the costs for the population of peo-ple they predominantly serve.”

“Accountable care has real potential for moving our system toward safer, more effective, and less wasteful treatments. Person-centered services, such as indi-vidualized care planning, thorough communication and coordination of care, ongoing monitoring, meticulous medication management and early response to problems, make economic sense.”

Reforming healthcare to make it ratio-nal is not the same thing as rationing, wrote Byock. “The best care gives peo-ple every chance of living longer and well.”

He cites the law’s language which spe-cifically states that IPAB’s recommen-

Wikimedia Commons and U.S. Navy photo by Mass Communication Specialist 2nd Class Gary Granger Jr.

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201211dations cannot “include any recom-mendation to ration health care, raise revenues or Medicare beneficiary pre-miums…increase Medicare beneficiary cost-sharing (including deductibles, coinsurance, and co-payments), or oth-erwise restrict benefits or modify eligi-bility criteria.” Physicians and Surgeon Shortages?

Yes, wrote Suzanne Sataline and Shirley S. Wang, of The Wall Street Journal in an April 12, 2010 article.

They write that experts warn there won’t be enough doctors to treat the millions of newly insured people. “At current graduation and training rates, the nation could face a shortage of as many as 150,000 doctors in the next 15 years, according to the Association of American Medical Colleges.”

The U.S. has 352,908 primary-care doctors now, and the college associa-tion estimates that 45,000 more will be needed by 2020. But the number of medical-school students entering fam-ily medicine fell more than a quarter between 2002 and 2007.

Orthopedic Surgeons and Procedure Volumes

It’s not just primary care physicians.

Peter Pollack wrote in AASO Now in January 2009 that aging baby boom-ers and an increase in the number of obese patients will double the demand for arthroplasty over the next decade.

According to a paper presented by Thomas K. Fehring, M.D., at the Ameri-can Association of Hip and Knee Sur-

geons 2008 annual meeting, decreased interest among residents in choosing careers in adult orthopedic reconstruc-tion is likely to result in a shortage on the supply side.

Fehring found that 7,585 AAOS fel-lows perform hip and/or knee arthro-plasty, including 5,973 general ortho-pedists with a hip and knee focus, and 1,612 hip and knee specialists. The two groups perform a total of 337,047 total hip arthroplasties (THAs) and 418,542 total knee arthroplasties (TKAs) in one year.

Assuming orthopedic graduation rates remain stable between 2008 and 2016, Fehring determined that 1,584 general-ists with a hip and/or knee focus and 400 hip and/or knee specialists would enter the arthroplasty workforce.

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201212Assuming surgeons retired at age of 59, 3,338 generalists and 901 specialists would retire by 2016. This would result in a 31% decrease in the total number of generalists and a 32% decrease in the total number of specialists.

Fehring’s projections indicate that as many as 427,500 THAs and more than 1 million TKAs will be needed by 2016. The orthopedic workforce, however, would only be able to perform 231,071 THAs and 287,759 TKAs in 2016. That’s a shortfall of 195,929 THAs (46%) and 758,241 TKAs (72%).

However, the American College of Physicians (ACP) in an April 2010 fact sheet says the new law includes numer-ous policies to train more primary care physicians and increase the supply of primary care physicians.

“These policies include: mandatory and increased discretionary funding for the National Health Service Corp (NHSC), reauthorization of Section 747 of Title VII, Training in Family Medicine, Gen-eral Internal Medicine, General Pedi-atrics, and Physician Assistantship; creation of a Primary Care Training Extension Program and increased fac-ulty scholarship loans, redistribution of 65% of the current unused Gradu-ate Medical Education slots to primary care and general surgery and allowing residents to count their time spent in

ambulatory settings to count towards their residency requirements, such as physician offices and community health centers; and the establishment of Teaching Health Centers, creating pri-mary care residency programs in non-hospital settings.”

Unchartered Waters

We are in unchartered waters. Clearly demand will rise, surgeons are retiring

and a broken public purse will require making choices of care, especially, as the current president of the American Academy of Orthopaedic Surgeons, John Tongue, M.D., has said, end of life care. Data will replace rhetoric as policymakers and providers learn the answers to these questions. ♦

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201213Medicare Clawing Back Reimbursements!...Key to Happiness for Orthopedists?...HospitalSuccess Drives Shoulder Surgery Value…Roy Sanders, M.D. Named Health Care Hero…By Elizabeth Hofheinz, M.P.H., M.Ed.

Key to Happiness for Orthope-dists? Ray Baker, M.D. is president

of the International Spine Interven-tion Society and a former president of the North American Spine Society. He tells OTW, “Obamacare, the recession, a decline in innovation, and an aging population leaves orthopedists under-standably worried. Next month, I will be giving yet another talk on the future of spine care. As I pondered a way to discuss the future and put it into per-spective, it occurred to me that what physicians are really concerned with is happiness. I know it sounds ephemeral and ‘soft’, but in reality what people really want is a fulfilling career and a ‘good life’. In researching happiness, I did not look at the self-help section; I went to the scientific literature. And, to my surprise, I found that there is a great deal of hard data on what makes people happy. What I found was a message that might help all of us as we navigate these challenging times.”

“Research clearly shows that increas-ing income beyond an average wage does not make people happy, and some studies actually show an inverse rela-tionship. Self-image and status are also transient, and do not lead to sustained happiness. What brings sustained hap-piness? There are several factors, but three stand out in the research: autono-my, mastery, and purpose. Put succinct-ly, we are happiest when we feel that we have control over our destiny, when we are very good at what we do, and when

that mastery is used in the service of something larger that ourselves.”

“None of us know where healthcare is going, who will be elected, and what other changes are headed our way. Truth be told, it might have less effect on us than we think. All of us can probably remember, when we were first entering medicine, being told by a retiring phy-sician that the ‘Golden Age’ of medi-cine had past. Well, for me, that was 23 years ago and now I hear my col-leagues saying that to younger physi-cians. It appears to me that the ‘Golden Age’ of medicine is defined as the peri-od of medicine ending precisely when you begin practice. But in the end, true satisfaction and happiness comes from

people who are meaningfully engaged in their work in helping others. They will continue to work to find solutions and to innovate; they will thrive. I’m not being Mother Teresa here. I’m just saying that we need to keep our eye on the ball and focus on what is truly important. As I said at the conclusion of my NASS presidential address, you can climb the ladder of success to find that it is leaning against the wrong wall.”

Medicare Clawing Back Reimburse-ments! There’s at least one joint replacement surgeon who is increas-ingly shocked by the government’s role in healthcare. He tells OTW, “Just a few months ago there was a study in the Journal of Bone and Joint Surgery

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201214looking at the Surgical Care Improve-ment Project (SCIP) guidelines, which are supported CMS [Centers for Medicare and Medicaid Services] as a measure of quality. The research-ers analyzed data from 128 New York state hospitals and measured how well each facility adhered to the CMS antibiotic recommendations. They found that the hospitals that followed those guidelines best had no improve-ment in their infection rates. To make things worse, they found that increas-ing adherence to the SCIP guidelines regarding anticoagulant use after sur-gery actually led to an increase in the infection rate. It is astounding to me that this study was not repeated all over the national media. Adherence to these recommendations doesn’t change care, it actually creates more complications…yet hospitals across the country have spent significant funds in developing programs that adhere to and track their adherence to the guidelines…this doesn’t bode

well for government intervention in healthcare.”

“I’m sorry to say that our future doesn’t look so bright in some ways. CMS is currently having consulting companies decide which patients should qualify for joint replacement surgery. There is a list of requirements regardingwhat theX-raysmust show, a list of requirements regard-ing what treatments the patients must have already tried, and requirements as to what the surgeon has to find on the physi-cal exam. The problem is that the con-sulting company’s recommendations look ridiculous to surgeons, as they appear somewhat arbitrary and not evidence based. These decisions made by unmoni-tored groups will certainly limit access to care, and may even lead to a lower quality of care by taking the decisions out of the physicians’ hands.”

“And to top it off, physicians could be audited and financially penalized years later if we do not adhere to their guide-

lines. Medicare can ‘claw back’ your reimbursements years after the surgery was done. They can audit our patient decisions and tell the surgeon, ‘Your surgical decisions did not strictly fol-low our guidelines for who qualifies to have a joint replacement. Therefore we are taking back a percentage of your previous reimbursements as a penal-ty.’ The problem is that their national guidelines for medical care are not evi-dence based, are still controversial, and in certain circumstances may lower the quality of care and limit access to care.”

Hospital Success Drives Shoulder Surgery Value Mark Frankle, M.D. is a shoulder specialist at the Florida Ortho-paedic Institute and researcher with the Foundation for Orthopaedic Research and Education (FORE). Awhile back he started wondering, ‘What is the value of shoulder arthroplasty?’ Here he tells OTW about his study, a four-year look at the value of shoulder replacement, which was recently presented at the

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201215October 2012 Closed Meeting of the American Shoulder and Elbow Society. “We wanted the costs to be measur-able and readily apparent to the patient and payers…how much did the entire episode of care cost and what were the benefits? We wanted to limit the subjec-tivity of the ‘benefits’ so we used objec-tive range of motion measurements and strength measured by an independent therapist pre- and postop. We included 83 primary total shoulder arthroplasty (TSA) patients and 55 reverse shoulder arthroplasty (RSA) patients.”

“As for cost data we sought out experts, who broke costs down as follows: we started the cost meter going at the pre-op visit, we included hospitalization, and then the follow-up care post-hospi-talization. It was helpful that our hospi-tal had standard methods of calculating costs. For each of the 83 TSA patients and each of the 55 RSA patients we cap-tured every cost that occurred—and we did so using in-hospital costs given to us by the hospital. For home health therapy and surgeon fee, we used Medi-care reimbursement. If the patient was readmitted we looked at that cost and we then recognized some variation in patient cost so we wanted to sort out the drivers of cost in these groups.”

“The cost drivers: in TSA patients, it turned out that the number of comor-bidities didn’t make a difference but in RSA it did. The most surprising finding was that the surgeon fee was only 8% of the total cost for the TSA group and only 6% for the RSA group. This would probably surprise those in the media that assume surgeons are responsible for a large portion of the costs of care.

Also, the fact is that the federal govern-ment wants to make one bundled pay-ment for the entire episode of care. So with shoulder arthroplasty, they don’t

want to pay a fee to the anesthesiologist, a fee to the surgeon and a fee to the hos-pital, etc. They want to write one check to one entity. We sought to discover what these costs were ourselves so that we can be a part of the process. I was also hoping that in doing this that other centers would start to measure their costs and outcomes the way we did.”

Irreparable Fractures No More! Anand Murthi, M.D. is chief of the Shoulder and Elbow Service and Direc-tor of Shoulder and Elbow Research at Medstar Union Memorial Hospital in Baltimore, Maryland. He has just com-pleted an interesting study on irrepara-ble coronoid fractures. Dr. Murthi tells OTW, “There are many patients with severe elbow trauma who, to date, have not been able to get much assistance. This is especially true if they have a com-minuted coronoid fracture. In some of these cases they are unreconstructable because the bones are fragmented and the only the option is to do an anterior capsulodesis where you repair the ante-rior capsule to the coronoid fracture bed of the elbow, and leaving patients with a stable, but stiffer elbow. So my colleagues and I began experiment-ing with cadaveric elbows and when we were reviewing their anatomy we wondered, ‘What if we take the tip of the olecranon a part of the bone that is unused and has no issues with being removed and transfer it as an autograft. It ended up that it was a near perfect anatomic replica of the coronoid (we flipped it around and put it where the coronoid used to be). Our biomechani-cal research shows that this renders the elbow very stable and doesn’t increase contact pressures in the elbow—which is excellent because these pressures make someone more prone to arthritis. We are submitting our manuscript for publication now, and will soon begin using this treatment on patients.”

Roy Sanders, M.D. Named Health Care Hero The Tampa Bay Business Journal has honored Dr. Roy Sanders, president and chief medical officer at Florida Orthopaedic Institute, with a Health Care Heroes Physician Award for 2012. Chosen by an independent panel of judges, Dr. Sanders was select-ed from more than 200 nominees. Dr. Sanders has more than 27 years’ experi-ence as an orthopedic surgeon special-izing in acute trauma, post-traumatic reconstruction and foot and ankle sur-gery. He is one of the original found-ers of Florida Orthopedic Institute, and has served as president and board chair for more than 15 years. Since 1991, Dr. Sanders has worked as chief of depart-ment of orthopedics at Tampa General Hospital and has authored more than 100 articles and abstracts on orthopedic trauma as well as developed approxi-mately 20 patents that are issued and used locally and internationally. ♦

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201216Pellegrini Battles Padgett Over DVT AnticoagulantsBy Elizabeth Hofheinz, M.P.H., M.Ed.

“Balance,” argues Vincent Pel-legrini. “I accept less effective

prevention of venographic disease to avoid bleeding complications, but I still want effective prevention of clini-cal events.” “The biggest issue now is safety,” says Doug Padgett. “And there are better and safer alternatives to che-moprophylaxis.”

This week’s Orthopaedic Crossfire® debate is “DVT Anticoagulants: Con-temporary Standard of Care.” For the proposition was Vincent D. Pellegrini, Jr., M.D. of the University of Mary-land School of Medicine in Baltimore. Against the proposition was Douglas E. Padgett, M.D. from the Hospital for Special Surgery (HSS). Moderating was Steven J. MacDonald, M.D., F.R.C.S.(C) of the University of Western Ontario.

Dr. Pellegrini: “If we choose to prevent every venographic clot by definition we will have to accept more bleeding. If we choose to be more selective in our pre-vention and worry about clinical pul-monary embolism (PE) and death, we can have less bleeding and accept some venographic clots.”

“The American College of Chest Phy-sicians (ACCP) guidelines came out against aspirin…and gave a seal of approval to Warfarin, fractionated Heparin, and Fondaparinux. The softer recommendation is duration, but they landed on about 35 days. The Ameri-can Academy of Orthopaedic Surgeons (AAOS) charged a task force to focus on clinical events and bleeding risk. There

is a paucity of data and the AAOS rec-ommendations pointed to bleeding as a concern. As you elevate the risk of bleeding from standard prophylaxis or standard risk, aspirin and Warfarin are the only two drugs that survive. When there’s an elevated risk of thrombosis, as well as an elevated risk of bleeding, aspirin and Warfarin are still the only ones, so bleeding risk trumps PE risk.”

“One classic argument that orthopedists have is that there’s a poor correlation between venographic clot and clinical events, and while they aren’t synony-mous, there is a well proven relation-ship between the two—if you reduce one the other also reduces. Tradition-ally, Warfarin has a residual clot risk of about 20%, with general [anesthesia],

and 10% with regional anesthesia after hip replacement. Fractionated Hepa-rin gets that residual clot rate down to 10%. If we look at knees, they’ve been rather refractory to effective prophylax-is; even to fractionated Heparin their residual clot rate is around 30%. But with fractionated Heparin the bleeding risk increases two- to three-fold.”

“So our therapeutic compromise is based on a balance. I accept less effec-tive prevention of venographic disease to avoid bleeding complications, but I still want highly effective prevention of clinical events. Over the last 20 years we’ve looked at this with venogram surveillance. For the first decade if the patient didn’t get a venogram we did not continue their prophylaxis. For

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201217the second decade if they got no veno-gram we were concerned and had seen some adverse events and gave Warfarin upon discharge. If you left the hospital on Warfarin you had nearly seven-fold reduced risk of being readmitted for a clot after hip arthroplasty. The data were similar for knees, with about a four-fold reduction; if you combine the data there wasn’t a single PE in 20 years that occurred in a patient that left the door with Warfarin.”

“The risk of bleeding with low intensity Warfarin was one tenth of 1%. What the Warfarin does in low intensity is provide effective secondary prophy-laxis even though it doesn’t prevent the initial clot from forming; it effectively prevents embolization.”

“Other modalities: the greatest advance in the ACCP guidelines two versions ago was that they acknowledged a high risk of bleeding perioperatively is optimally managed with mechanical prophylaxis. But after that bleeding risk resolves, you must use a chemoprophylaxis of some sort. The study by Paiement suggested a twice high rate of proximal clots with pneumatic compression alone. Our data suggests it’s four fold with pneu-matic compression alone, without che-moprophylaxis after hip arthroplasty.”

“The NIH [National Institutes of Health] some 20 years ago told us aspirin wasn’t very good; it became more popular in the 90s, largely because of the prob-lems with fractionated Heparin. The Antiplatelet Trialists’ Study is frequent-ly studied: with elective hip and knee arthroplasty with aspirin alone only 24-60 patients…doesn’t really tell us anything.”

“The Pulmonary Embolism Prevention Trial—a hip fracture trial. If you look at

elective arthroplasty there was no dif-ference between aspirin and placebo. If you look at meta-analysis, a study from the University of Pennsylvania suggests that the anesthetic effect of aspirin is irrefutable. A study from the Hospi-tal for Special Surgery showed a very effective prophylaxis with hypotensive epidural anesthesia and unfractionated Heparin, with very low PE rate. With regional anesthesia there was a readmis-sion rate of only 0.5%”

“Some newer agents have no known antidote, and we often recognize new and untoward side effects, but they’re never telling us new drugs have greater safety. Rivaroxaban, a factor 10 inhibi-tor, is the most highly studied new drug—nearly 13,000 new patients in trials. There were so many patients that they’ve shown us there was a clinically increased risk of major bleeding and clinically important bleeding with this drug. Dabigaran—similar bleeding rate to Enoxaparin.”

“I believe the best compromise is bal-ancing low bleeding, high efficacy…and clinical endpoint should be our bottom line.”

Dr. Padgett: “I vehemently oppose this. If the major risk of VTE [venus throm-boembolism] is PE, and if 90% of the PE originate from deep vein thrombo-sis, and if therefore we reduce the DVT [deep vein thromobosis] rate, perhaps we can reduce the PE rate and underly-ing fatalities associated with this.”

“Why thromboembolic events? It’s the Virchow’s triad [hypercoagulation at top, stasis and endothelial damage at bottom].The thesis of my opponent has been that the optimal way to prevent VTE and its complications is to use anti-coagulants addressing the hypercoagu-

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201218able aspect of this triad. There are better and safer alternatives to this.”

“Strategies to reduce VTE events are largely driven towards chemoprophy-laxis. Why? Money. The basis of this has been the recommendations of the ACCP; the grades of recommendations have been based upon methodologic strength and the clarity of perceived risk and benefit.”

“Current ACCP guidelines: low molec-ular weight Heparin, Fondaparinux, and adjusted dose Warfarin with a tar-get INR of 2.5; recommendations are against aspirin, low dose Heparin and intermittent pneumatic compression solely as an agent. ACCP guidelines are sponsored by big pharma, the inves-tigators are all consultants, and they downplay the risks of anticoagulation.”

“Exhibit A: a meta-analysis of potent anticoagulants—a study performed at our institution—over 28,000 patients looking at all cause mortality. They were grouped into potent anticoagulants:

group A had low molecular weight Heparin, oral anti-thrombin agents, etc; group B was the HSS protocol which combined spinal epidural, aspirin, and pneumatic compression; group C was the Warfarin group. The results that the highest all cause mortality and the highest rate of non-fatal PE occurred in groups A and C, with the lowest rates occurring in group B.”

“More importantly is exhibit B…the failure of the ACCP article that was submitted by Robert Barrack and coau-thors. The authors switched from using their standard Warfarin techniques for DVT prevention to the use of the ACCP guidelines using Lovenox. The intend-ed protocol was approximately a 10 day course for total hips and knees with an intention to treat 1,500 patients. After less than 300 patients were enrolled, 9% of the patients presented with major complications: a readmission DVT rate of 3.8%, a 5% readmission rate, and a 3.4% reoperation rate for wound drain-age. The study was terminated by the IRB [Institutional Review Board].”

“If limb torsion is associated with restriction of blood flow and decreased blood flow leads to stasis and sta-sis leads to thrombosis, then why not mechanical compression. DVT preven-tion using mechanical devices has been studied in total hips and knees, and it has a systemic effect by releasing endo-thelial derived relaxing factors and uro-kinases, and has a systemic endogenous fibrilytic effect.”

“The advantages of mechanical com-pression: nearly complication free, it’s safe, and time worn appears to be related to the effectiveness. Disadvan-tages: applied often after surgery, worn only in the hospital, and compliance is an issue. ActiveCare, the CECT Sys-tem—Continuous Enhanced Circula-tion Therapy—it’s miniature, portable, battery powered, applied at the time of surgery and the patients can go home with it. It’s triggered with inspiration cycle to maximize venous return.”

“We did a multicenter randomized trial that we published this year in the Jour-

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201219nal of Bone and Joint Surgery (JBJS). We looked at the hypothesis of superi-ority, and the efficacy and safety of the device compared to Enoxaparin. We looked at a consecutive series of total hips that were performed unilateral. In the CECT arm the device was applied in the OR, surgery was performed, and patients received an aspirin per day, skin checks, and follow up at 10-14 days with a three month clinical fol-low up. In the Lovenox arm there were no compression devices; Lovenox was administered BID [twice a day], and we evaluated the patients at 10-14 days (sutures out, Doppler study, both lower extremities) and a three month clinical follow up.”

“We used no general anesthesia, but we did avoid the profound hypotension that we actually prefer at HSS, so mean arterial pressure was >60; Intravenous Patient-Controlled Analgesia for pain. We monitored major and minor bleed-ing, looking at drops in hemoglobin, rehospitalization, as well as fatalities. There were 411 patients consented. We found no difference in the distribution of DVT by either the Lovenox group or the compression device, as well as the incidence of PE. The bleeding indices tended to be lower in the compression device. Most significant was the major bleeding events: none in the compres-sion device, minor bleeds were less than 25%, however in the Lovenox arm there were 6% major bleed and 31% minor bleed. Compliance rate: mean use was for 11 days (intended use of the device was 10-14 days). But we could

not demonstrate relationship between DVT and the use of the device.”

“The object of total hip: perform it well, make it safe, and reduce the risks. We clearly demonstrated efficacy between the two modalities; we demonstrated the indisputable safety of this device in regards to the risk of postoperative bleeding after total hip.”

Moderator MacDonald: “So Vinny…is Doug crazy?”

Dr. Pellegrini: “The paper that was the lead article in the JBJS earlier this year was not powered to determine efficacy—only to determine safety. Nowhere under the sun can we have 200 patients in each group and deter-mine a statistically significant differ-ence in an event that occurs less than 1% of the time. That study was sup-ported by a commercial entity and was designed to prove safety. I’m excited by the device, but that paper doesn’t help me get there. Another point: there are three Level 1 trials in the literature—prospective, randomized studies—of chemoprophylaxis versus pneumatic compression full length of leg, that show higher proximal clot rates with pneumatic compression alone.”

Dr. Padgett: “Most of the prior studies on intermittent pneumatic compres-sion were done during the hospital period where patients actually stay in the institution, which is approximately three days. It’s probably unlikely that these days it is sufficient to do the trick.

Also, if the initiating event occurs at the time of surgery you might say that use of a pneumatic compression device intraoperatively is the way to go. You’re right that our study was not powered enough to demonstrate the efficacy; we did demonstrate, however, and it was powered strong enough for the safety. But the biggest issue now is safety.”

Moderator MacDonald: “Thank you, gentlemen.” ♦

Please visit www.CCJR.com to register for the 2012 CCJR Winter Meeting, December 12 - 15 in Orlando, Florida.

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201220

company

Stryker’s New CEO Lowers Expectations

Kevin Lobo, Stryker Corporation’s new president and CEO’s first job

was to lower expectations.

Stryker had been without a permanent leader since last February, when Steven MacMillan was sent packing for per-sonal behavior unacceptable to some members of the company’s board. Dur-

ing that time, the company’s near leg-endary double-digit earnings growth rate took a hit.

Third quarter net sales of $2.1 billion, up only 1% from the previous year’s quarter were, in Lobo’s words, disappointing. “As a result we are lowering our earn-ings outlook for 2012 and 2013,” Lobo told analysts. “We expect market condi-tions to remain challenging in Europe and for capital equipment.” He also told analysts that with the new 2.3% device tax taking effect in 2013 and an esti-mated $100 million impact, the Stryker will not be able to meet previous earn-

ings growth projec-tions. The company had previously announced layoffs to cover the tax.

New Forecast

The new forecast for 2012 includes a

constant currency sales increase of 4% to 5.5%, with foreign currency nega-tively impacting revenue by approxi-mately 0.5% to 1.5% for the full year. Lobo said the company plans to meet the lowered expectations.

Reconstructive

Reconstructive net sales of $891 million decreased 1.1% in the quarter over the prior year, as reported. Net sales in the quarter grew by 2.4% due to increased unit volume and changes in product mix and 0.1% as a result of acquisi-tions. On a reported basis, hips sales dropped 3.9%, knees increased 1.4%, trauma and extremities declined 0.7% and spine dropped 1.6%.

Management said U.S. sales led con-stant currency growth with knees up in the mid-single-digits, reflecting the early impact from the company’s GetAroundKnee direct-to-consumer campaign. The drop in reported hip revenue reflects tougher year-over-year comparisons and a modest impact from the Rejuvenate recall.

Joanne Wuensch, BMO Capital Mar-ket analyst, said the company’s ADM X3MobileBearingHip Systems (now22% of hip sales), continue to experi-ence healthy demand, and the Accolade II launch is proceeding above expecta-tions, noting it’s the No. 1 selling stem in the U.S. after only two quarters on the market.

Given a chance to echo previous com-ments by competitors that physician-owned distributors (PODs) and payer pushback were culprits for slow spine sales, company management told ana-lysts they saw no “meaningful changes” in that area.

Source: Stryker Corporation

Stryker 3Q 2012Sales

$ in million% Change*

Reported Reconstructive Sales $891 down 1.1%

Hips $288 down 3.9%

Knees $315 1.4%

Trauma/Extremities $235 down 0.7%

Spine $175.0 down 1.6%

Kevin Lobo, President/CEO - Stryker Corp

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201221Lobo Looks Ahead

Turning business around in Europe will be his first job, said Lobo. He cited mar-ket and internal company problems for the sales declines and promised new leadership on the Continent. He also said he will be finding someone to fill in his own, departed roles as head of orthopedics.

“In closing,” Lobo told analysts, “Q3 presented challenges, while also underscoring the potential we have to deliver solid underlying revenue growth. Although the issues impact-ing our international businesses will not be resolved in a single quarter, I’m confident that we will be taking the necessary measures to ensure we first get back to market growth, while also ensuring we are realizing the lever-age in the P&L. We have a number of important product launches underway throughout the company, coupled with a focus on driving greater operating efficiencies through our global quality and operations teams, which will drive $500 million of cost savings over the next five years.”

The disappointing results and lowered expectations didn’t spook investors. Mizuho analyst Mike Matson said that while Stryker faces a number of chal-lenges; he thinks these are well-under-stood by investors and mostly priced into Stryker shares at current levels.

So Kevin Lobo’s first quarterly joust with Wall Street analysts is now behind him. He lowered expectations and promised modest improvements. Machiavelli would be proud.

—WE (October 21, 2012)

J&J’s Ortho’s 3QDebut

Johnson & Johnson’s orthopedic fran-chise (formerly DePuy), excluding

the impact of the Synthes acquisition in December 2011, grew sales by approxi-mately 2.5% on an operational basis in the third quarter of 2012. Including Synthes, reported sales of $2.290 bil-lion were a 65.5% increase over the previous year.

Hips, Knees, Spine and Trauma

Operationally, hips were up 3% world-wide driven by 6% growth in the U.S. due to strong results in primary stem platform sales partially offset by contin-ued pricing pressure. Hips outside the U.S. were flat with soft sales in Europe offsetting gains in other regions. Com-petitive pressures and the softer mar-ket impacted growth in Europe.

Knees worldwide increased 3% on an operational basis with the U.S. up 6% driven by fixed bearing and revi-sion platforms. Sales outside the U.S. were flat due to softer sales primarily in Europe due to competitive pressure. Including the Synthes business and excluding the divested DePuy trauma business, trauma grew approximately 4% on an operational basis with the U.S. up 1% and sales outside the U.S. up 7% on an operational basis. U.S. growth was impacted by shipping pat-terns.

Including the Synthes business, world-wide spine was down 3% on an opera-tional basis with the U.S. down approx-imately 6% with continued pressure

Source: Johnson & Johnson * Constant Currency** ex Synthes

J&J Orthopaedics 3Q 2012Sales

$ in million%

Change*

Total Reported Sales $2,290 2.5%**

Large Joints 3.0%

Knees 3.0%

Hips down 3.0%

Trauma 4.0%

Source: Johnson & Johnson

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201222on price. Outside the U.S., sales grew approximately 1% operationally.

Payers and Utilization Rates

When asked about comments by com-petitors citing insurer pushback for spine procedures, company officials said they did not see that in their busi-ness, though the payers have been “asking for evidence in the spine world for many, many years.” They said they believed it was just a continued trend.

Dominic Caruso, the company’s CFO, told analysts on October 16 that U.S., healthcare utilization rates, primar-ily hospital admissions and surger-ies, show early signs of stabilization, and U.S. joint reconstruction volumes appear to have improved. “While some positive signs can be seen, these signs are still too early to signal any meaning-ful recovery...We’ve now seen a couple quarters of these low rates of growth,

and of course they’re not exciting low rates of growth but they’re not declines which is what we saw for the previ-ous nine quarters, and more growth in orthopedic procedures in particular.”

Caruso also noted that the company recorded a $94 million after tax increase in the accrual for DePuy ASR hip related costs, based on updated international registry information.

Synthes Integration

Regarding Synthes integration, Caruso said it was early since closing the deal in mid-June. “Our first priority is no dis-ruption to customers. But the updates that we’re getting tell us that things are moving along just fine. We’re integrating obviously the spine businesses, because they’re the two businesses that we had that were similar. So that’s where the bulk of the integration is occurring.”

“And so far so good. We’re going to take this carefully. We’re going to be measured in the way we do this so that there’s very little disruption if any, and we’re confident that’s the right way to do it for the long term. The leaders are intact. We’re very pleased to have the Synthes leadership team join Johnson & Johnson, and as you all know, Michel Orsinger, the previous CEO of Synthes now leads our entire combined ortho-pedics business.”

Overall, the company’s Medical Devices and Diagnostic Segment had sales of $7.1 billion, up 16.1% on an opera-tional basis as compared to the same period in 2011. Currency had a nega-tive impact of 3.6 points resulting in a total sales increase of 12.5%.

—WE (October 18, 2012)

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201223Orchid Design Launches New Website

Orchid Design is announcing the launch of its new website, a move

designed to achieve additional gains in capabilities awareness and market rec-ognition. Orchid Design states that it is leveraging the industry recognition of parent organization, Orchid Orthope-dic Solutions.

The company indicates that its new website (http://design.orchid-ortho.com) highlights the company’s people, categories of services, and examples of engineering projects in multiple indus-try segments. Capitalizing on Orchid Design’s customized services for com-mercializing medical devices are many of the world’s leading surgeon inven-tors, innovative medical device start-ups, and global orthopedic companies alike.

Orchid Design’s Business Development Manager Kyle Mullens stated in the October 9, 2012 news release, “We’re excited about the launch of our new website and the opportunity it brings to

demonstrate Orchid Design’s capabili-ties and experience to a broader audi-ence. With our team’s clinical experi-ence and broad knowledge of orthope-dic devices, we have the expertise and resources to be a valuable development partner, with our new website being one gateway for potential new clients to see where there’s a good fit for their needs.”

Mullens told OTW, “Orchid Design’s site is a newly launched site separate from Orchid Orthopedics corporate site, so the changes are dramatic and focus on our business focus for assist-ing device companies, entrepreneurs and surgeon inventors with commer-cializing devices. We’ve highlighted our teams, our categories of services and industry experience with examples of engineering projects in broad industry segments. And within our category of services, there are details on our three core areas of focus—Product Design & Development, Regulatory & Quality Systems, and Prototyping/Customs & Specials.”

—EH (October 17, 2012)

Wright In the Clear

The Era of Deferred Prosecution Agreements (DPA) has come to a

close as the industry’s most painful and drawn-out DPA has been put to bed.

On October 8, Wright Medical Group, Inc. announced the DPA entered into with the feds on September 29, 2010 has expired. The company said it has

satisfied its obligations under the DPA and has received a Notice of Dismissal of the Complaint filed against it by the U.S. Attorney in New Jersey.

Robert Palmisano, who took over as president and CEO of the company after the feds charged the company, said, “We have taken significant steps to ensure that we successfully complet-ed the DPA and have an effective, sus-tainable, global compliance program. While exiting the DPA is an important milestone, executing an effective and Orchid Design

Wright Medical Group, Inc./Image created by RRY Publications LLC

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201224efficient compliance system and pro-moting the highest standards of ethical and legal conduct in all of the markets that we serve will remain a focal point for the company.”

The company remains subject until September 29, 2015 to the terms of a Corporate Integrity Agreement it entered into with the Office of Inspec-tor General of the U.S. Department of Health and Human Services.

Wright’s tortuous journey through the DPA was filled with firings and depar-tures of senior executives and compli-ance officers, a 12-month extension of the original DPA, surgeon training disruptions and wrongful termination lawsuits by former employees.

We think this ends the DPA Era as all major hip and knee makers are now in the clear from charges filed by the U.S. Attorney for paying surgeons to use their products. The companies will be required to publicly disclose payments to physicians when the Sunshine Law under the Affordable Care Act takes effect next year.

—WE (October 16, 2012)

TranS1 Inc. Enters Middle Kingdom

Medtronic, Inc. wasn’t the only company making China news

this past month.

On October 10, Wilmington, North Carolina-based TranS1 Inc. announced the signing of a distribution agreement with Beijing Jiade Sunshine.

The distribution agreement covers the sale of AxiaLIF products in China with the exception of Hong Kong, Macau and Taiwan. The company’s AxiaLIF

implants were granted a registration certificate by the State Food and Drug Administration (SFDA) and the remain-ing instrumentation is expected to receive its respective registration in the fourth quarter of 2012.

“The knowledge gained in the 13,000 AxiaLIF cases completed in the U.S. and Europe combined with our strong focus

on surgeon training will help to drive success in China,” said Ken Reali, presi-dent and CEO of TranS1. “The Chinese spinal fusion market is large and grow-ing and we believe the minimally inva-sive AxiaLIF lower lumbar fusion sys-tem will represent an attractive option for surgeons and their patients.”

“We are delighted to enter a long term partnership with TranS1 to offer such an innovative technology as AxiaLIF to spine surgeons and patients throughout China,” said Ming Ming Tian, president of Jiade. “Minimally invasive spine sur-gery (MISS) is rapidly expanding in China, and our vast, spine experienced, national distribution network is well positioned to advance adoption of this unique, but tested, MISS technology to present to their surgeons.”

Beijing Jiade Sunshine, a joint-stock enterprise, is a national distribution company in The People’s Republic of China. Jiade currently markets implants and other operating room products to spine and orthopedic surgeons. Jiade has made investments in developing experienced surgical marketing, pro-fessional sales and academic training teams throughout the Chinese market. Jiade was founded in March 2007.

—WE (October 16, 2012)

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201225

Bone Regeneration Focus of New Firm

A former Medtronic, Inc. executive and an Emory University ortho-

pedic surgeon have partnered to form

SkelRegen, LLC, a company focused on regenerating human bone and other skeletal tissue. One of the partners, Ste-phen R. LaNeve, was president of the spinal and biologics division of Minne-sota-based Medtronic. The other, Scott D. Boden, M.D., is chief medical offi-cer at the Emory University Orthopae-dic & Spine Hospital and a professor of Orthopaedics at Emory University School of Medicine.

As reported by John George in the Philadelphia Business Journal, the two hope to find new approaches to repair-ing damaged bone, cartilage, ligaments and tendons. Their firm is located in West Chester, Pennsylvania.

As Boden explained, options for sur-geons are presently limited to the use of biologically inactive space fillers or

expensive recombinant proteins, pep-tides, and antibodies. With SkelRegen, the two hope to produce safe and less-expensive small molecule treatments that would be capable of regenerating skeletal tissues using the body’s own mechanisms.

“We discovered several small molecules that simply help the body’s own regen-eration machinery do its job,” said Boden, who serves as the company’s chief medical, science and technology officer. “We are basically building bone from scratch now, with the expectation of building cartilage and other soft tis-sue in the near future.” Boden oversaw the research team, led by Emory Ortho-paedics researcher Sreedhara Sangadala that discovered the molecules.

—BY (October 19, 2012)

biologics

Courtesy of SkelRegen

Ankle Replacements –Growing Stepchild of Hips & Knees

Although the basic technology for ankle replacements was devel-

oped about 30 years ago, widespread acceptance did not take off—as it did for hips and knees—in part because the ankle technology was not yet satis-factory. In the 1970s, “everybody gave up on them,” said James Bodsky, M.D., an orthopedic surgeon in Dallas and a clinical professor of orthopedic surgery at the University of Texas Southwestern Medical School. He is quoted October 17 by Ellyn Couvillion of the Baton Rouge Advocate.

That situation has now changed and Brodsky finds ankle replacement to be “a very exciting area. It does a huge

amount of good.” The ankle joint holds different challenges for surgeons than do the hip or knee surgeries, which may account for the longer timeline in the development of successful ankle pros-theses and related technology.

“The ankle joint is a very unforgiving joint; there are basically bones on three sides of it,” said Steven Haddad, M.D. a spokesperson for the American Acad-emy of Orthopaedic Surgeons and an orthopedic surgeon in Wilmette, Illi-

extremities

Wikimedia Commons and FA Renlis

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201226nois, who specializes in foot and ankle issues. “The ankle bone is about a quar-ter the size of the knee. It’s a small inter-face for the prosthesis to grow into the bone.”

As Couvillion explained, the ankle joint is actually formed by three separate bones: the lower end of the shinbone, the lower end of the smaller leg bone and the top of the foot bone. In an ankle replacement procedure, the surgeon removes the damaged portions of those bones and reshapes them. The parts of the new artificial joint are then attached to the bony surfaces. Recovery typically entails a partial cast or splint following surgery, followed by a hard cast, then a walking cast or boot for several weeks before physical therapy begins.

Since the ankle has the weight of the entire body on it, the forces on the ankle are greater than those on either the hips or the knees. Brodsky notes that, “It requires extensive knowledge about the biomechanics of the foot and ankle. It’s quite complicated. The foot and ankle have to be well-aligned.”

The Food and Drug Administration has approved four ankle prosthetics for use in the U.S., although there are about 50 in use throughout the world. A major benefit of ankle replacement is that the person retains movement in the ankle joint. On the negative side is the fact that the implants are not permanent; they last an average of 10 years. For that reason it is rare for people in their 20s and 30s to have the ankle replace-ment surgery. A further problem is that some insurance companies, according to doctors, are still calling the surgery experimental.

—BY (October 19, 2012)

New Treatment for Shoulder SLAP Tear

Michael Terry. M.D., an orthope-dic surgeon and sports medicine

specialist at Northwestern Memorial Hospital and Northwestern University Feinberg School of Medicine, recom-mends an alternative treatment for a SLAP tear, a shoulder injury that often requires surgery and up to four months of rehabilitation.

A SLAP tear occurs in a part of the shoulder called the labrum, which is a cuff of cartilage that forms a cup for the arm bone to move within. This type of tear often specifically affects the biceps tendon, a cord-like structure connect-ing the biceps muscles to the bone at the shoulder as it travels toward the elbow, Terry said. Athletes who make repetitive overhead actions, such as baseball pitchers or swimmers are most

prone to these injuries because of the enormous stress those activities place on the shoulder.

The alternative minimally invasive sur-gery which Terry performs—biceps tenodesis—is an outpatient arthroscop-ic procedure during which the surgeon treats the tear via two small incisions to cut the normal attachment of the biceps tendon then reattaches it to a position that is out of the way of the shoulder joint.

“Biceps tenodesis is a relatively new way to treat superior labral tears, but it’s quickly gaining popularity,” Terry said. “Most patients who undergo this pro-cedure find that they are able to return to activity in six to ten weeks; other options may require double that time for recovery and rehabilitation.”

—BY (October 19, 2012)

Wikimedia Commons and rwillia4

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201227

Two New FDA Rul-ings Expand Integra’s Product Offerings

Earlier this month, the Food and Drug Administration approved an

expanded use for Integra LifeScienc-es Holdings Corporation’s Vu aPOD, an intervertebral body fusion device (IBD) for use in anterior lumbar fusion (ALIF) procedures. The new indication includes four points of fixation com-posed of two screws and a SpinPlate.

“Earlier this year the Vu aPOD™ Prime IBD entered its full market release with stand-alone indications,” said Kirt Ste-phenson, president, U.S. Spine. “We’re pleased that with this additional indica-tion, we can now provide surgeons with multiple fixation options to best meet their patients’ needs.”

As Integra’s October 9 release explained, “IBDs are designed to help provide sta-bility for spinal fusion after a diseased lumbar disc is surgically removed. They are small, hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and allow fusion between vertebral bodies. These devices relieve pressure on the nerves and provide positive mechanical stabilization of the vertebrae. The graft window in the device is packed with bone and provides an environment in which natural bone growth can occur, which then enables fusion of the verte-bral segments.”

Traditionally, surgeons use supple-mental fixation to help hold the IBD in place. The Integra Vu aPOD Prime IBD features two zero-profile options utilizing two screws or two screws and a SpinPlate to help secure the IBD in its functional position, eliminating

the need for supplemental fixation implants, and reducing the number of steps and implants required to perform an ALIF procedure.

“The Integra® Vu aPOD™ Prime IBD provides surgeons with an easy and safer approach when compared to other devices that have four points of fixa-tion with four screws, and a very mini-mally invasive way to provide stability of the anterior lumbar spine, with no additional sharp objects introduced to the outside of the spine,” said Jaideep Chunduri, M.D., a design surgeon from Beacon Orthopaedics and Sports Medi-cine in Cincinnati, Ohio. “It is often dif-ficult to place screws laterally within the lumbar spine. Integra’s SpinPlate™, in conjunction with two screws, enables four-point fixation without significant retraction. Because the SpinPlate™ is also located within the middle of the device, and provides built-in fixation, there is no added risk in terms of blood loss or vascular tissue. “

New Bone Tip

Shortly after announcing its Vu aPOD news, Integra rolled out its latest device

at the Chicago Congress of Neurologi-cal Surgeons. It is a bone tip for the CUSA NXT Ultrasonic Tissue Abla-tion System. The new bone tip, which has received FDA clearance, allows surgeons to use ultrasonic tissue abla-tion in procedures requiring precise, controlled bone removal near critical structures where the rotational motion of a drill or frictional heat could be a concern.

The tip features a working surface ori-ented towards the bottom surface of the tip, making it useful in situations where the surgical setting requires downward pressure for bone removal. “The orien-tation of the new tip will help neuro-surgeons during cases when they are approaching the bone from above. The tip also generates less heat, which can be important in certain surgical pro-cedures,” said Bob Davis, President of Integra’s Neurosurgery business. The company reports that over 2,000 cen-ters now rely on the CUSA ultrasonic surgical ablation technology for a vari-ety of procedures.

—BY (October 19, 2012)

spine

Courtesy of Integra Life Sciences

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VOLUME 8, ISSUE 34 | OCTOBER 23, 201228

Hans Koelsch, Ph.D. to Lead Publications at AAOS

There is a new publications sheriff in town…and he will be ensuring

that orthopedists worldwide have the information they need to be their best. The American Academy of Orthopaedic Surgeons (AAOS) has announced that Hans Koelsch, Ph.D. will be the orga-nization’s new director of publications. Dr. Koelsch will oversee and guide the Academy’s text and periodical publish-ing program. In this role Koelsch also will direct the overall planning, bud-geting, development and production of both Academy print and online publi-cations.

“As we look to the future, we must focus on making products such as eBooks and websites more compelling to our mem-bers and the public at large to ensure they come to the AAOS for their needs related to orthopaedic surgery,” stated Koelsch in the October 12, 2012 news release. “I look forward to collaborating with AAOS member volunteers, mem-bers of the senior management team, and other Academy staff members.”

Dr. Koelsch served in senior publishing positions for over 20 years at Springer Science + Business Media, LLC. Most recently, he served as the company’s editorial director of mathematics for North America. Some of his previous positions at Springer included direc-tor of editorial cooperations for China and Eastern Europe, as well as editorial director for physics at Springer’s New York office.

“Dr. Koelsch has in-depth experience managing scholarly publishing across

divisions and disciplines,” said Chief E d u c a t i o n Officer Con-stance Filling. “He also brings a wealth of k n o w l e d g e and exper-tise based on his work with learned societ-

ies and publishing programs in North America, Europe and China.”

Dr. Koelsch grew up in Mannheim, Germany, and was a researcher at Freie Universität in Berlin, and at École Polytechnique Fédérale de Lausanne in Lausanne, Switzerland, prior to his work at Springer. He studied chemistry and philosophy in undergraduate and graduate school, and earned a Ph.D. in physics from Freie Universität.

—EH (October 17, 2012)

McCollum Takes Over Orthofix SpineBusiness

Brian McCollum is moving. The Orthofix International N.V. chief

financial officer is taking over the com-pany’s Spine Global Business unit. He’s replacing his colleague, Bryan McMil-lan, who is leaving due to family rea-sons.

Bob Vaters, Orthofix’s president and CEO, says he likes McCollum’s “strong track record of success within the com-pany.” He added that McCollum’s oper-ational and financial experience, “along with increased financial flexibility will allow us to take the Spine Global Busi-ness Unit to the next level.” Vaters was

also the company’s CFO when he joined the company in 2008.

During his 11 years with the company, McCollum has served in various opera-tional and financial executive roles. Most recently, he managed the com-pany’s operating margin improvements and led the divestiture of the sports medicine business, which significantly deleveraged the company.

In 2011, he was named CFO, after having served as senior vice president of Finance in 2010. He joined Ortho-fix’s corporate finance group in 2001 advancing to the position of corporate controller. In 2006 he became vice president of Finance, Americas, and two years later became vice president of International Finance and Group Trea-surer. Prior to joining Orthofix, McCol-lum was a senior audit associate with PriceWaterhouseCoopers. He received his B.S. in Business Administration, with concentration in Accounting, from St. Andrews Presbyterian College.

McCollum will stay on as CFO until November 10. Then, Emily Buxton will take over as interim CFO. Buxton has been with the company in various roles of increasing responsibilities for the past nine years, most recently as the CFO of the Global Orthopedics Busi-ness Unit.

—WE (October 17, 2012)

people

Hans Koelsch, Ph.D.; AAOS.org

Brian McCollum/Orthofix International N.V.

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