MVAD Platform Steven W Boyce M D Surgical
® MVAD Platform Steven W. Boyce, M. D. Surgical Director, Advanced Heart Failure Program Med. Star Heart and Vascular Institute 1
I, Steven W Boyce, 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. 2
MVAD® Platform leverages core impeller design One platform, multiple configurations MVAD® Pump Circu. Lite® Full-support; next-generation versatility Partial-assist; hybrid cath lab placement Longhorn™ Full-support; transapical; minimally invasive 3 CAUTION: MVAD, Longhorn, and Circu. Lite are Investigational devices. Limited by Federal (or United States) law to investigational use
Wearless impeller technology engineered for breakthrough hemocompatibility • >50% reduction in shear stress* - Optimized flow paths to guide 99% of blood through ultra-low stress, high-flow blood channels - Smooth impeller edges to decrease forces applied on blood - Small priming volume & reduced surface contact to limit blood time in the pump *Compared to the HVAD pump, Heart. Ware data on file 4 CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.
MVAD® Pump designed for surgical ease and versatility • • • Supports a broad range of patients with varied anatomy and physiology - 70% smaller* enables intrapericardial placement across patient populations - Full flow to support large BSA and the most advanced heart failure patients - Partial flow to enable weaning and lower flow applications Optimized cannula positioning via the Gimbaled Sewing Ring - Angle adjustment enabling optimal anatomical alignment - Depth adjustment supporting smaller heart chambers Implantation via thoracotomy may lead to: - Smaller incisions and less surgical trauma - Reduced blood product utilization - Shorter ICU time, ventilator time, and LOS *Pump volume compared to HVAD® Pump 5 CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.
Gimbaled Sewing Ring enables pump depth and angle adjustments 6 CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.
Longhorn™ Pump Minimally invasive implant • Intraventricular pump placement with outflow cannula positioned across the aortic valve • Procedural intent: ― Small, single incision (similar to Transapical TAVR) ― ‘Off pump’ implant procedure Potential benefits • Eliminate CPB • Reduce LOS • Reduce blood utilization CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.
Circu. Lite® System: Two configurations designed to supplement native cardiac output Potential benefits • Less invasive • Eliminates CPB • Extubated in OR • Shorter ICU time • Shorter LOS Circu. Lite® Surgical Minimally invasive surgical implantation • Inflow cannula placed in left atrium • Graft anastomosis to subclavian artery • Pump placed in subcutaneous pacemaker-like pocket Circu. Lite® Endovascular Percutaneous interventional system • Inflow cannula transseptally deployed in left atrium via the subclavian vein and right atrium • Graft anastomosis to subclavian artery • Pump placed in pacemaker-like pocket Not available for sale. CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use. Potential benefits • Interventional procedure • Significantly shorter LOS
PAL Patient Peripherals: Designed to improve Qo. L • Simplified patient experience with streamlined design – Integrated controller and battery system – Snap-on, cable-free battery attachment – Time-based (hours and minutes) battery run-time display • Designed for increased patient safety and confidence – Internal battery for back-up power – Clear and actionable text-based alerts – Enhanced data access on controller for improved remote troubleshooting – Durable controller cable with shock absorber feature to support patient activity and reduce stress on driveline Peripherals for an Active Lifestyle 9 CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.
PAL Patient Peripherals: Enhanced mobility and freedom for an active lifestyle • Lightweight controller and 2 battery sizes to match varied patient needs and physical abilities – 5 hour, lightweight Single Battery for ease of carrying – 10 hour Dual Battery for extended use • Charge batteries through the controller when plugged into power adapters • Public discretion with quiet, vibratory alerts preceding audible low priority alarms 10 CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.
MVAD Advantage™ CE Mark Trial • Multi-center, prospective, non-randomized, single-arm trial • 70 patients at 11 sites in Australia, Austria, France, Germany & the UK • Patients with advanced AHA Stage D/NYHA Class IIIB/IV heart failure who have failed optimal medical management • Primary Endpoint: Survival at 6 months • Implantation via thoracotomy or sternotomy • 11 patients implanted (first patient enrolled July 2015) • Trial currently on voluntary enrollment hold as company evaluates changes to MVAD System For more information, visit Clinical. Trials. gov CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use. 11
The MVAD® platform has breakthrough potential • Remain confident in MVAD platform • MVAD® System has the potential to meaningfully improve patient outcomes MVAD® Pump ― Small size to enable less invasive implant and improved anatomical fit ― Advanced impeller technology for reduced shear ― Thoughtfully designed peripherals to enhance patient quality of life • Have conducted rigorous testing with objective to replicate, and then mitigate, clinical events • Analyzing potential changes to address clinical events to enable return to clinic MVAD® Impeller PAL Patient Peripherals 12 CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.
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