MKC0212-01 Rev.A. 2 Renaissance ® Value in Spine Surgery Improves Patient Care What is Renaissance?...

MKC0212-01 Rev.A

2

Renaissance® Value in Spine Surgery

Improves Patient Care

What is Renaissance?

Enhances hospital offering

Enhance Surgeon Capabilities & Safety

3

Planning Software

Workstation

Guidance Unit

4

Step 4:Operate

Step 2:Mount

Step 3:3D Sync

Spine Surgery with

How It Works

Step 1:Preoperative plan

Tools and implants are guided to theplanned trajectory with 1.5mm accuracy

5

Clamp Mount

4 mounting platforms ̶

Bed Mount

Hover T Mount Multi-directional Bed Mount

6

Spinal fixation─ Pedicle screws─ Transfacet, translaminar-

facet screws─ Sacroiliac screws

Spinal deformities ─ Scoliosis posterior spinal fusion,

osteotomies

Cement augmentations─ Kyphoplasty and vertebroplasty

Oncological applications─ Biopsies, tumor resections

Revisions

Posterior approaches (open, MIS, percutaneous)

Applications in Spine Surgery

7

PatientCare

ClinicalChallenges

HumanFactor

OccupationalRisk

• Over 7,500 successful procedures worldwide

• Over 45,000 implants placed

Surgeons’ experience

8

Mazor Robotics Technology:

Clinical Evidence

98.3% Accuracy of 3,271 implants in 635 cases in 14 medical centers

with 49% of implants placed percutaneously

(typically 10%-20% of spine surgeries are MIS)

Devito DP, Kaplan L, Dietl R, et al. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine J. 2010;35(24):2109-2115.

9

Mazor Robotics Clinically Validated Technology:

Clinical Evidence

99.7% Clinical Acceptance of 1,815 implants in 120 scoliotic adolescentsDevito DP, Gaskill T, Erikson M, Fernandez M. Robotic based guidance for pedicle screw instrumentation of the scoliotic spine. Presented at Pediatric Society of North America (POSNA); May 2011; Montreal, Canada.

10

Mazor Robotics Technology:

Clinical Evidence

Compared to freehand surgery, in 112 cases Mazor Robotics technology:

• Improved implant accuracy

• Reduced fluoroscopy by 56%

• Reduced complication rates by 48%

• Reduced re-operations 46%

• Reduced average length of stay 27%Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, GieseA, Rohde V. Perioperative course and accuracy of screwpositioning in conventional, open robotic-guided andpercutaneous robotic-guided, pedicle screw placement.Eur Spine J. 2011;20(6):860-868.

11

98.9% “successful and accurate” screw placement in deformity and revision surgeries• 960 screws in 95 patients

Hu, X, Ohnmeiss D. Lieberman,I. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J (2013) 22:661-666.

Mazor Robotics Technology:

Clinical Evidence

12

Compared to previously published results on vertebral augmentation, procedures performed using Mazor Robotics technology in this study demonstrated 74 percent reduction in radiation exposure when compared to using fluoroscopic guidance, and a 50 percent reduction in radiation exposure when compared to using navigation technology.

• 33 Consecutive patients with 60 vertebral compression fractures

Barzilay, Schroeder, Hiller, Singer, Hasharoni, Safran, Liebergall, Itshayek, Kaplan. Robotic assisted vertebral body augmentation - a radiation reduction tool. Spine Journal: Volume 39, Number 2, pp 153-157.

Mazor Robotics Technology:

Clinical Evidence

13

100 percent of screws placed in the 2mm safe zone• Study of 12 cases utilizing Renaissance with varying

indications: sagittal and coronal plane deformity, DDD, revision surgery (100 percent performed percutaneously after stage 1 anterolateral interbody fusion).

Graham M, Murtough R, James C, Castellvi E. Accuracy, Safety, & Intraoperative Radiation in Robot Guided Percutaneous Screw Placement. Presented at Current Solutions in Spine Surgery; May 2013; Duck Key, Florida, USA.

Mazor Robotics Technology:

Clinical Evidence

Adolescent Idiopathic Scoliosis (AIS) data presented at the International Meeting on Advanced Spine Techniques (IMAST) 2014

• Multi-site (Five centers) • 223 AIS patients, 3,274 screws

placed with Mazor Robotics system• 3,252 of 3,274 screws were

considered accurate = 99.3%• 1.58 seconds of fluoroscopy per

screw

Mazor Robotics Technology:

Clinical Evidence

Devito D, Hegde S, Lieberman I, Bederman S, Woo, R. Retrospective, Five-Center Analysis of 3,270 Pedicle Screws Placed with Robotic Guidance in Adolescent Idiopathic Scoliosis (AIS). Presented at International Meeting on Advanced Spine Techniques; July 2014; Valencia, Spain.

Mazor Robotics in the United States

Mazor Robotics System

Training Center

Multi-System Accounts

US Locations by State

California____________________________________________Desert Regional Medical Center, Palm SpringsFountain Valley Regional Hospital, Fountain ValleyTri-City Medical Center, Oceanside (2)University of California, Irvine Medical Center

Colorado____________________________________________Parker Adventist Hospital, DenverLittleton Adventist Hospital, Littleton

Florida______________________________________________Baptist Health Jacksonville, Jacksonville (2)Delray Medical Center, Delray BeachDoctors Hospital of SarasotaFlorida Hospital Carrollwood, TampaFlorida Hospital Celebration Health, CelebrationFlorida Hospital for Children, OrlandoFlorida Hospital OrlandoLawnwood Regional Medical Center, Fort Pierce

US Locations by StateGeorgia_______________________________________________________________

Children’s Orthopaedics of AtlantaNorth Fulton Hospital, RoswellSavannah Memorial Hospital, SavannahThe Medical Center of Central Georgia, Macon

Michigan_____________________________________________________________Michigan Surgical Hospital, DetroitMetro Health Hospital, Grand Rapids

Nebraska____________________________________________________________Bryan Medical Center, Lincoln

New York____________________________________________________________St. Mary’s Healthcare, AmsterdamNathan Littauer Hospital, Gloversville

North Carolina______________________________________________________New Hanover Regional Medical Center, Wilmington

Ohio__________________________________________________________________Bethesda North Hospital, Cincinnati

US Locations by State

Pennsylvania___________________________________________________Geisinger Health System, Danville

South Carolina_________________________________________________ Spartanburg Regional Healthcare System, Spartanburg

Tennessee______________________________________________________St. Francis Hospital, Memphis

Texas____________________________________________________________Foundation Surgical Hospital of San AntonioHouston Orthopaedic & Spine HospitalHumble Surgical Hospital, HumbleSouthwest NeuroSpine Institute, El PasoTexas Health Presbyterian, Plano Trinity Mother Francis, TylerWestside Surgical Hospital, Houston (2)

US Locations by State

Virginia__________________________________________________________Reston Hospital Center, Reston

Mazor Robotics in Europe

Mazor Robotics System

Europe Locations

Germany_________________________________________University Medical Center Gottingen, GottingenUniversity Medical Center Mainz, MainzUniversity Tuebingen, TuebingenHSK, WiesbadenPfaffenhofen Ilmtalklinik GMBH, PfeffenhofenKlinikum Muenchen Schwabing, MunichKlinikum rechts der Isar, MunichKlinikum Grosshadern, MunichParacelsus Klinik Muenchen, MunichKlinikum Nordstadt Hannover, Hannover

Italy_____________________________________________ARS Medica, Rome

Switzerland_______________________________________Geneva HUG-Hospitaux Universitaires, Geneva

Europe Locations

The Netherlands___________________________________Medisch Spectrum Enschede, EnschedeBergman Clinics, Naarden

Turkey___________________________________________Florence Nightingale Hospital, Istanbul

Mazor Robotics in Asia

Mazor Robotics System

Asia Locations

Australia__________________________________________ North Shore Private Hospital, Sydney

India_____________________________________________ Apollo Hospital, Chennai

NOVA Orthopaedic and Spine Hospital, New Delhi

Russia____________________________________________ Federal Orthopedic Center of Cheboksary, Cheboksary Krasnoyarsk Regional Hospital, Krasnoyarsk Civil Aviation Hospital, Moscow N.N. Blokhin Cancer Research Center, Moscow City Clinical Hospital, #67, Moscow

Taiwan__________________________________________ Kaohsiung Medical University Memorial Hospital (KMUH), Kaohsiung

Vietnam_________________________________________ Viet Duc, Hanoi

Mazor Robotics in Middle East

Mazor Robotics System

Middle East Locations

Israel__________________________________________Bnai Zion Medical Center, HaifaCarmel Medical Center, Haifa Hadassah Medical Center, JerusalemMeir Medical Center, Kfar SabaShaare Zedek Medical Center, Jerusalem

27

Renaissance® Value in Spine SurgeryImproves Patient Care• Safer1

• Fewer complications and revisions4,5

• Less post-operative pain4

• Shorter recovery time3

Overcomes Clinical Challenges• CT-based 3D planning• Accuracy independent of anatomical challenges and field-of-view1,3,5

• Optimize implant location

Increase Occupational Safety• May reduce fluoroscopy4Enhances hospital offering

• Differentiates spine program• Attracts new surgeons and

new patients• May increase operating

room efficiencies

Enhance Surgeon Capabilities• 98.3 % accuracy5

• 99.7% clinical acceptance1

• Short Learning Curve2,5

REFERENCES

1. Devio DP, Gaskill T, Erikson M, Fernandez M. Robotic based guidance for pedicle screw instrumentation of the scoliotic spine. Presented at: Pediatric Society of North America (POSNA); May 2011; Montreal, Canada.

2. Pechlivanis I, Kiriyanthan G, Engelhardt M, et al. Percutaneous placement of pedicle screws in the lumbar spine using a bone mounted miniature robotic system, _ rst experiences and accuracy of screw placement. Spine.

2009;34(4):392–398.

3. Silberstein, B. Bruskin, A. Alexandrovskii, V. Robot guided surgery in treatment of osteoporotic fractures. [CD-ROM] Presented at: European Federation of National Associations of Orthopaedics and Traumatology (EFORT) 2011 Annual

Congress; June 1-4, 2011:abs 1097.

4. Kantelhardt, SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur

Spine J. 2011;20(6):860-868.

5. Devito, DP, Kaplan, L, Dietl R, et al. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine. 2010;35(24):2109-2115.

28www.MazorRobotics.com

www.MazorRobotics.com

http://www.youtube.com/user/MazorRobotics