MKC0212-01 Rev.A
Renaissance® Value in Spine Surgery
Improves Patient
Care
Enhances hospital
offering
What is Renaissance?
Enhance Surgeon
Capabilities & Safety
2
Planning Software
Workstation
Guidance Unit
3
Spine Surgery with
How It Works
Step 1:
Preoperative
plan
Step 2:
Mount
Step 3:
3D Sync
Step 4:
Operate
Tools and implants are guided to the
planned trajectory with 1.5mm accuracy
4
4 mounting platforms ̶
Clamp Mount
Bed Mount
Hover T Mount
Multi-directional Bed Mount
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Applications in Spine Surgery
Posterior approaches (open, MIS, percutaneous)
Spinal fixation
─ Pedicle screws
─ Transfacet, translaminarfacet screws
─ Sacroiliac screws
Spinal deformities
─ Scoliosis posterior spinal fusion,
osteotomies
Cement augmentations
─ Kyphoplasty and vertebroplasty
Oncological applications
─ Biopsies, tumor resections
Revisions
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Surgeons’ experience
•
•
Over 7,500 successful procedures worldwide
Patient
Clinical
Over 45,000 implants
placed
Care
Challenges
Human
Factor
Occupational
Risk
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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 adolescents
Devito 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, 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.
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Mazor Robotics Technology:
Clinical Evidence
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.
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Mazor Robotics Technology:
Clinical Evidence
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.
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Mazor Robotics Technology:
Clinical Evidence
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.
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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
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
Multi-System Accounts
Training Center
US Locations by State
California____________________________________________
Desert Regional Medical Center, Palm Springs
Fountain Valley Regional Hospital, Fountain Valley
Tri-City Medical Center, Oceanside (2)
University of California, Irvine Medical Center
Colorado____________________________________________
Parker Adventist Hospital, Denver
Littleton Adventist Hospital, Littleton
Florida______________________________________________
Baptist Health Jacksonville, Jacksonville (2)
Delray Medical Center, Delray Beach
Doctors Hospital of Sarasota
Florida Hospital Carrollwood, Tampa
Florida Hospital Celebration Health, Celebration
Florida Hospital for Children, Orlando
Florida Hospital Orlando
Lawnwood Regional Medical Center, Fort Pierce
US Locations by State
Georgia_______________________________________________________________
Children’s Orthopaedics of Atlanta
North Fulton Hospital, Roswell
Savannah Memorial Hospital, Savannah
The Medical Center of Central Georgia, Macon
Michigan_____________________________________________________________
Michigan Surgical Hospital, Detroit
Metro Health Hospital, Grand Rapids
Nebraska____________________________________________________________
Bryan Medical Center, Lincoln
New York____________________________________________________________
St. Mary’s Healthcare, Amsterdam
Nathan 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 Antonio
Houston Orthopaedic & Spine Hospital
Humble Surgical Hospital, Humble
Southwest NeuroSpine Institute, El Paso
Texas Health Presbyterian, Plano
Trinity Mother Francis, Tyler
Westside 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, Gottingen
University Medical Center Mainz, Mainz
University Tuebingen, Tuebingen
HSK, Wiesbaden
Pfaffenhofen Ilmtalklinik GMBH, Pfeffenhofen
Klinikum Muenchen Schwabing, Munich
Klinikum rechts der Isar, Munich
Klinikum Grosshadern, Munich
Paracelsus Klinik Muenchen, Munich
Klinikum Nordstadt Hannover, Hannover
Italy_____________________________________________
ARS Medica, Rome
Switzerland_______________________________________
Geneva HUG-Hospitaux Universitaires, Geneva
Europe Locations
The Netherlands___________________________________
Medisch Spectrum Enschede, Enschede
Bergman 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, Haifa
Carmel Medical Center, Haifa
Hadassah Medical Center, Jerusalem
Meir Medical Center, Kfar Saba
Shaare Zedek Medical Center, Jerusalem
Renaissance® Value in Spine Surgery
Improves Patient Care
• Safer1
• Fewer complications and
revisions4,5
• Less post-operative pain4
• Shorter recovery time3
Enhances hospital offering
• Differentiates spine program
• Attracts new surgeons and
new patients
• May increase operating
room efficiencies
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 fluoroscopy4
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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www.MazorRobotics.com
http://www.youtube.com/user/MazorRobotics
www.MazorRobotics.com
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