Transcript HeartWare - R Starling

Update on MVAD Trial
HeartWare
INTERMACS Annual Meeting
Atlanta GA
March 11,12, 2016
Randall C Starling MD MPH FACC FESC
Professor of Medicine
Kaufman Center for Heart Failure
Department of Cardiovascular Medicine
Heart & Vascular Institute
Update on MVAD Trial
HeartWare
INTERMACS Annual Meeting
Atlanta GA
March 11,12, 2016
Randall C Starling MD MPH FACC FESC
Disclosure:
HeartWare MVAD Advisory Panel
Thoratec ROADMAP Study Steering Committee
No honoraria received 2015
LVAD Therapy: Future
• LVADs will evolve and improve
– Totally implanted with power supply
– Smaller and lighter
– MUST reduce adverse events
• Improved technology will expand the use of
LVAD
• LVAD use in less ill patients…..
• Cost reduction ESSENTIAL
Coagulopathy in Mechanical Circulatory Support:
A Fine Balance
Rosenthal J, Starling RC Curr Cardiol Rep 2015 Dec;17(12):114.
ROADMAP Trial
AEs were more frequent in LVAD patients than in OMM patients. Bleeding
was the primary driver of LVAD AE
Estep J et al J Am Coll Cardiol 2015 Oct 20;66(16):1747-61.
The MVAD System: New Technology
• Small size enables less invasive
implant and improved
anatomical fit
MVAD® Pump
• Advanced impeller technology
• Lighter and thoughtfully designed
peripherals to enhance patient
quality of life
PAL Patient Peripherals
Exclusively for Clinical Investigation.
Investigational device to be used by Qualified Investigators Only.
CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.
HEARTWARE, HVAD, MVAD and the HEARTWARE logo are registered trademarks of HeartWare.
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MVAD® pump compared to HVAD®
• MVAD is less than 1/2 the size of HVAD
– 22 cc displacement volume
– 5 cc priming volume
• Small 85 g pericardial device that provides up to 7 L/min of
cardiac support
• 70 cm driveline with reduced velour length (20 cm).
• Extraction line to ensure device is properly inserted into
sewing ring
CAUTION – Investigational Device. Limited by United States law to investigational use.
Exclusively for Clinical Investigations.
HEARTWARE, HVAD, MVAD and the HEARTWARE logo are registered trademarks of HeartWare.
Advanced Impeller Technology
Proven wearless impeller technology engineered for
breakthrough hemocompatibility
• >50% reduction in shear stress*
 Smooth impeller edges to decrease forces applied on blood
 Small priming volume & high-throughput design to limit
blood time in the pump
 Reduced surface contact to decrease blood & pump interaction
 Optimized flow paths to guide 99% of blood through
ultra-low stress, high-flow blood channels
*Compared to the HVAD pump, HeartWare data on file
HEARTWARE, HVAD, MVAD and the HEARTWARE logo are registered trademarks of HeartWare.
MVAD
MVAD® Pump
Designed for surgical ease and versatility to support the spectrum
of advanced heart failure patients
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Supports a broad range of patients with varied anatomy and physiology

70% smaller* ensures intrapericardial placement across patient populations
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Full flow to support large BSA and the most advanced heart failure patients
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Partial flow to enable weaning and lower flow applications
Optimized cannula positioning via the Gimbaled Sewing Ring
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Angle adjustment enabling optimal anatomical alignment
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Depth adjustment supporting smaller heart chambers
Implantation via thoracotomy may lead to
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Smaller incisions and less surgical trauma
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Reduced blood product utilization

Shorter ICU time, ventilator time, and length of stay
*Pump volume compared to HVAD® Pump
Exclusively for Clinical Investigation.
Investigational device to be used by Qualified Investigators Only.
CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.
HEARTWARE, HVAD, MVAD and the HEARTWARE logo are registered trademarks of HeartWare.
qPulse™ Cycle
Customized pulsatility designed to promote aortic valve opening, enable ventricular washing, and
reduce bleeding complications
Off, low, medium, and high settings to provide patient-specific cycles
Exclusively for Clinical Investigation.
Investigational device to be used by Qualified Investigators Only.
CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.
HEARTWARE, HVAD, MVAD and the HEARTWARE logo are registered trademarks of HeartWare.
PAL Patient Peripherals
Peripherals to provide improvements in patient
quality of life
• 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
CAUTION: Investigational Device. Limited by
United States law to investigational use.
HEARTWARE, HVAD, MVAD and the HEARTWARE logo are registered trademarks of HeartWare.
Peripherals for an Active Lifestyle
World’s smallest heart pump fitted to British man
Bogota 2015
Daily Telegraph; 30 Juli 2015
MVAD® in-situ
CAUTION: Investigational Device. Limited by
United States law to investigational use.
HEARTWARE, HVAD, MVAD and the HEARTWARE logo are registered trademarks of HeartWare.
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MVAD trial
CE trial:
• Multi-center, prospective, non-randomized, single-arm CE trial
• 70 patients at 11 sites in up to 5 countries (Germany, UK,
Austria, France & Australia)
• Patients with advanced AHA Stage D/NYHA Class IIIB/IV heart
failure who have failed optimal medical management
• 11 patients implanted (first implant in July 2015)
• CE Mark clinical trial currently on voluntary pause
• Company is evaluating MVAD System performance
CAUTION – Investigational Device. Limited by United States law to investigational use.
Exclusively for Clinical Investigations.
HEARTWARE, HVAD, MVAD and the HEARTWARE logo are registered trademarks of HeartWare.
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