[2014]

2 References 1. Kosmopoulos V, Schizas C. Pedicle screw placement accuracy: a meta-analysis. Spine. 2007;32(3):E Gertzbein SB, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine. 1990;15(1): Singer, Occupational radiation exposure to the surgeon, Am Acad Ortho Surg. 2005;13: Mastrangelo G, Fedeli U, Fadda E, Giovanazzi A, Scoizzato L, Saia B. Increased cancer risk among surgeons in an orthopaedic hospital. Occup Med. 2005;55(6): Saia55(6 Increased cancer risk for spine surgeons 3,4 10% misplaced screws 1 0.8% - 2% permanent nerve damage 2 Anatomical challenges (i.e. deformities, revisions) Field-of-view (i.e. MIS) Safe Successful Definitive Patient Expectations Clinical Challenges Occupational Risk Human Factor

 Only FDA-approved robotic guidance system for spinal surgery  Accuracy in screw placement < 1.5mm  Over 7,500 procedures performed  Over 45,000 screws placed  Available at only 68 sites worldwide

Posterior Surgical Approaches:  Open  MIS  Percutaneous Thoracic, Lumbar, Sacrum:  Spinal Fixation  Pedicle screws  Transfacet, translaminar- facet screws  Sacroiliac screws  Spinal Deformities  Scoliosis PSF, osteotomies  Cement Augmentations  Kyphoplasty and vertebroplasty  Oncological Applications  Biopsies, Tumor resections  Revisions

Goals:  Improve accuracy with screw placement  Higher confidence and safety in difficult areas  May reduce use of fluoroscopy  Maintain standard operative time  Improve screw insertion times, especially in cases of difficult anatomy  Can use for all levels of difficulty: minimally-invasive, percutaneous and complex/deformity cases

7 7 Step 1: Preoperative Plan Step 4: Operate Step 2: Mount Step 3: 3D Sync Preoperative blueprint of the ideal surgery is created in a virtual 3D environment.

8 8 Step 1: Preoperative plan Step 4: Operate Step 2: Mount Step 3: 3D Sync Rigid attachment to the patient ensures maximum surgical accuracy throughout the procedure.

9 9 Step 4: Operate Step 2: Mount Step 3: 3D Sync Two fluoroscopy images are synchronized with the CT- based surgical blueprint (independent of anatomy). Step 1: Preoperative plan

10 Step 4: Operate Step 2: Mount Step 3: 3D Sync Step 1: Preoperative plan Tools and implants are guided to the planned trajectory with 1.5mm accuracy.

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):

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):

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.

98.9% “successful and accurate” screw placement in 960 screws in 95 patients (deformity and revision surgeries) Hu, X, Ohnmeiss D. Lieberman,I. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J (2013) 22:

 FDA-cleared for brain surgery  Renaissance Brain Module commercially released April 2014  Being utilized by neurosurgeons for deep brain stimulation (DBS) and brain biopsies