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MKC0212-01 Rev.A
2
Renaissance® Value in Spine Surgery
Improves Patient Care
What is Renaissance?
Enhances hospital offering
Enhance Surgeon Capabilities & Safety
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Planning Software
Workstation
Guidance Unit
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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
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Clamp Mount
4 mounting platforms ̶
Bed Mount
Hover T Mount Multi-directional Bed Mount
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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
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PatientCare
ClinicalChallenges
HumanFactor
OccupationalRisk
• Over 7,500 successful procedures worldwide
• Over 45,000 implants placed
Surgeons’ experience
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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.
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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.
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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.
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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
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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
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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
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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.
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