CathLab of The Future Robotic Enhanced PCI Giora

Cath-Lab of The Future: Robotic Enhanced PCI Giora Weisz, MD Director of Cardiovascular Clinical Research, Center for Interventional Vascular Therapy Columbia University Medical Center Cardiovascular Research Foundation New York, NY

Disclosure Statement of Financial Interest I, Giora Weisz, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

The Past Of Interventional Cardiology

The Future Of Interventional Cardiology

Contemporary PCI Challenges that impede success • Limited precision and control • STLLR trial reported 47. 6% Longitudinal Geographical Miss • 10 -20% of patients require a second stent due to inaccurate placement or size of first stent • Wire and device slippage • High doses of contrast media - CIN!

Contemporary PCI Occupational hazards in the cath lab

Interventionalists Reported Spine Injury

Vascular Robotic System Corindus - Cor. Path 200 Single-use Cassette Robotic Drive Interventional Cockpit Operator Console

Cor. Path. TM 200 Vascular Robotic System Single-use Cassette Robotic Drive Control console

Case Example

Loading Guide. Wire

Guide-wire Control

Device Manipulation

Precise Measurements • Unrelated to angiographic view • Not affected by foreshortening The measurement feature may be useful for determining lesion length for stent selection or understanding the distance between 2 branch arteries.

Complex Bifurcation Interventions

First-in-Human Experience

Devices • • • Cor. Path 200 6 Fr Guide catheter 0. 014” Rx guidewire Pre-dilatation baloons 2. 5 -3. 5 mm Stents: DES or BMS 2. 5 -4. 5 X 12 -24 mm

Technical Performance n=8 % Success 8/8 100% Advance 8/8 100% Cross lesion 8/8 100% Retrieval 7/8 87. 5% 8/8 100% Advance 8/8 100% Cross lesion & Dilatation 8/8 100% Retrieval 8/8 100% Advance 8/8 100% Cross lesion & Deployment 8/8 100% Retrieval 8/8 100% 71/72 98. 6% Guide Wire Pre-dilation Balloon Stent Overall Technical Success

Clinical Outcomes • CPK/MB ↑ 8, 16, 24 h 0% • MACE free @ 24 h 100% • Discharge @ 24 h 100% • MACE free @ 30 d 100%

Radiation Exposure (µGy) Table Operator Cor. Path Operator 97. 3 3. 78 41. 59 0 50. 5 0 12. 65 26. 91 Mean 97. 1% 3. 5 33. 33 3. 68 183. 0 0 47. 3 0 61. 57 ± 54. 95 1. 81 ± 1. 93

PRECISe Study Percutaneous Robotically-Enhanced Coronary Intervention Study • DESIGN: Prospective, nonrandomized, single-arm, multi-center clinical evaluation of the Cor. Path System. 9 Sites, n=164 • OBJECTIVE: To evaluate the feasibility, safety, and performance of the Cor. Path system • PRINCIPAL INVESTIGATORS: Giora Weisz, MD Joseph Carrozza, MD

Primary Endpoints • Clinical Procedural Success defined as <30% residual stenosis in target lesion at the completion of the procedure, in the absence of MACE* at 48 -hrs post index procedure or at hospital discharge, whichever occurs first. • Device Procedural/Technical Success defined as successful advancement and retraction of the PCI devices using Cor. Path 200 without conversion to manual operation.

Robotic Assisted PCI - 1 • Remote-control PCI in a relaxed and ergonomic sitting position will reduce radiation exposure and spine injury, further resulting in better ability to concentrate on the patient treatment rather than operator’s discomfort • The controlled Cor. Path robotic system can improve guiding-catheter stability, guide-wire manipulation, manage contrast media injections, improve visualization, and stent delivery with precise positioning

Robotic Assisted PCI - 2 • First-In-Human experience with the Cor. Path system demonstrated the safety and feasibility of using robotic technology for PCI • Technical success of the system was 98. 6% and clinical success was 100% without complications • The operator exposure to radiation was 97% less than at the table position

Robotic Assisted PCI - 3 • PRECISe, a prospective, multicenter, pivotal clinical study, was designed to confirm the safety, performance, and effectiveness of the Cor. Path vascular robotic system.