Evolution of Robotics Automation Remote Applications and Beyond
Evolution of Robotics: Automation, Remote Applications, and Beyond Introductions and Cor. Path GRX Overview SCAI 2019 Manish A. Parikh, MD, FSCAI Associate Professor of Medicine Associate Director, Cardiac Catheterization Laboratory Columbia University Irving Medical Center
Disclosures: § Current financial disclosures.
Interventional Procedures Today How the procedure is performed hasn’t changed in 40+ years • • • Performed with more predictability in recent years but optimization at a “hard stop” Innovation has been constrained to implantable devices (stents) Today’s interventional procedures remains largely unchanged ─ Radiation and orthopedic risk ─ Limits on the precision required in today’s complex cases Dr. Andreas Gruentzig Performs 1 st Angioplasty 1977 Traditional Intervention Cor. Path Robotic-assisted Intervention TODAY 3
Corindus Vascular Robotics Redefining vascular interventions Corindus Founded In Israel Company Relocates To United States FDA Clears Cor. Path 200 For use in PCI, results published in JACC Company Goes Public Trading on NYSE as CVRS FDA Clears Cor. Path GRX 2 nd generation technology for PCI FDA Clears 1 st Automated Robotic Move First step towards full procedural automation Expanded Approval for GRX in Japan & Australia Telerobotics Development Culminates in 1 st in human remote PCI in India Neuro Submission To FDA for expanded indication on Cor. Path GRX 2019 2018 2016 2014 2004 2012 2002 4
Robotics in the Interventional Suite Second-generation robotic system BEDSIDE UNIT • Optimized bedside unit for radial access • Simple setup & inprocedure workflow • Devices fixed during intervention • Imaging and device agnostic INTERVENTIONAL COCKPIT • Precise robotic control of ü Guide catheter ü Guidewire ü Rapid exchange catheter • Radiation-shielded workstation • 4 K resolution monitor 5
Traditional vs. Robotic Intervention Robotics can add value throughout the procedure Manual Intervention Today’s Cath Lab Environment • • High radiation exposure Significant fatigue and orthopedic strain STEPS Robotic-assisted Intervention Struggle to see angiography Assess Anatomy Close proximity, ergonomic visualization Trial & error, wire spinning Navigate Automated robotic techniques ‘Eyeball’ estimate Measure Anatomy Sub-millimeter measurement Manual adjustment Position Stent 1 mm precise positioning Devices loose during inflation Deploy Stent Devices fixed during deployment Robotic Cath Lab • • Shields from radiation Potential to reduce fatigue and orthopedic strain 6
The Need for Robotics in the Cath Lab Consistency & Reliability Reduce variability in operator skills and clinical outcomes (best clinical practices) Technology Integration Integrated imaging and data based decision making models to assist operator. Radiation Protection & Ergonomic Safety Physician and staff health concerns are rising as more evidence is generated on cath lab occupational hazards Improved patient care Access for All Patients Potential alternative delivery models – exploring feasibility of remote care for rural locations 7
Why Vascular Robotics Benefits for patients, physicians, & hospitals PATIENT BENEFIT • Robotic precision reduces stent utilization by 8. 3%1 • 17% reduction in radiation exposure to patient 2 • May facilitate increased radial adoption, which is shown to improve clinical outcomes PROTECTION FUTURE DIFFERENTIATION • 95% reduction in radiation exposure to physician 3 • Significant growth in robotic research and publications • Sit comfortably without the need for lead • Relevancy • Position hospital on the cutting edge by deploying robotics as part of a hi-tech cardiology model • 15% reduction in radiation exposure to bedside staff 4 • Involvement in tech development and medical education • Clinical leadership • Attract & retain physicians 1 Campbell PT, et al. The Impact of Precise Robotic Lesion Length Measurement on Stent Length Selection: Ramification for stent savings. Cardiovasc Revasc Med. 2015; piii: S 1553 -8389. 2 Smilowitz N, et al. Robotic-Enhanced PCI Compared to the Traditional Manual Approach. J Invasive Cardiol, 2014; 26(7): 318 -321. 3 Weisz G, et al. Safety and Feasibility of Robotic Percutaneous Coronary Intervention: PRECISE Study. J American College of Cardiol, 2013, Vol 61, No. 15: 1596 -1600. 4 Campbell et al. Staff Exposure to X-ray during PCI: Randomized Comparison of Robotic vs Manual Procedures. Presented at SCAI 2016. 8
Clinical Evidence for Robotics Proven benefit for patients & providers CORA-PCI Trial demonstrated 99. 1% clinical success in complex cases & comparable procedure times with manual PCI 1 JIC published single center trial showed reduced patient radiation dose with robotics compared to manual PCI 3 1 Mahmud E. , et al. JACC Cardiovasc Interv, 2017. 2 Weisz G, et al. JACC, 2013. 3 Smilowitz N, et al. J Invasive Cardiol, 2014. 4 Campbell P, et al. Cardiovasc Revasc Med, 2015. PRECISE trial demonstrated a 95% reduction in radiation exposure to primary operator 2 Study comparing robotic to manual PCI for measurement accuracy showed reduced stent usage 4 Data gathered using Cor. Path 200 9
Corindus Robotic Technology Potential to be first disruptive treatment option in vascular medicine in 40+ years Cleared PCI • Cor. Path GRX FDA clearance in late 2016 • Launched in 2017 • Over 2, 500 Cor. Path GRX procedures In Development PVI • Cor. Path GRX FDA clearance in 2018 • Focus on BTK, CLI, renal NEURO • Indication submitted to FDA in March 2019 • Steering committee established in 2018 NEURO + REMOTE • Target NG 3 launch with remote access capabilities in 2021 • Potential disruptor to stroke therapy with remote access capabilities • First remote in human remote PCI case completed in Dec 2018 10
The Capabilities of the GRX System
Robotic Precision From the Interventional Cockpit Robotic Precision defined as accurate controlled movements of devices by the Cor. Path System • Sub-millimeter measurement to determine lesion length and appropriate stent • Discrete 1 mm positioning of devices • Devices fixed in system during procedures • Procedural automation of wiring with Ro. R 12
Measurement Manual Challenges and Potential Solutions with Cor. Path Today’s Challenges ü Longitudinal Geographic Miss (stent too short/ too long) ü Increase late loss (too long) Potential Solutions With Cor. Path ü Sub millimeter measurement ü 1 mm Movements ü (In)Accuracy of lesion length & stent selection via visual estimation 13
Stent Savings 8. 3% stent reduction 4 • Inaccurate visual estimation leads to excess stenting • Treatment plan changed from 2 stents to 1 Visual Estimate Cor. Path Measurement Final result demonstrates successful lesion coverage Visual estimate = 44 mm Initial treatment plan = 24 + 20 mm stents Cor. Path = 28 mm Revised treatment plan = 32 mm˄ 14
Measurement Case Example Long LAD Lesion • Mid to distal ─ Visual estimate: 52 mm ─ Cor. Path measurement: 37. 7 mm • 38 mm DES placed to mid to distal LAD • 1 stent placed instead of 2 (24 + 28 mm) ─ 1 stent saved 15
Positioning Manual Challenges and Potential Solutions with Cor. Path Today’s Challenges ü Ostial Lesions ü Bifurcation Lesions Potential Solution With Cor. Path ü 1 mm advancement/ retraction with touchscreen ü In-stent Restenosis ü Distal anastamotic graft lesions 16
Placement Ostial Ramus Intermedius off of Left Main 17
Placement LAD Stent through LIMA 18
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