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Medtronic HeartWare HVAD System approved for destination therapy

Press releases may be edited for formatting or style | October 02, 2017 Cardiology

"Heart failure continues to be a growing burden to millions of patients, caregivers and the healthcare system," said David Steinhaus, M.D., vice president and general manager of the Heart Failure business, which is part of the Cardiac and Vascular Group at Medtronic. "Medtronic strives every day to advance the field of mechanical circulatory support so we can offer physicians more solutions for patients who are living with this debilitating disease."

About the HVAD System
The HVAD(TM) System features the world's smallest centrifugal-flow VAD and is designed to reduce surgical invasiveness, improve patient recovery times and enhance patient outcomes. Weighing only 160 grams, the HVAD System's continuous flow pump is 30 percent thinner and has 38 percent less volume than other centrifugal devices.3,4 The pump features a unique integrated inflow cannula that is designed to treat more complex patients while maintaining stable inflow position and eliminating the need for abdominal surgery and device pockets.5-12
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About the ENDURANCE Supplemental and ENDURANCE Trials
The ENDURANCE Supplemental trial was a prospective, randomized, controlled, multicenter evaluation of the incidence of neurologic events in patients receiving the HVAD System as destination therapy who received improved blood pressure management. Between October 2013 and August 2015, 465 patients were randomly selected to receive either the HVAD System or, as part of a control group, an alternative LVAD approved by the FDA for destination therapy, in a two-to-one ratio. Patients will be followed long term, up to five years.

This trial was a follow-up to the ENDURANCE Destination Therapy trial that implanted 445 patients between 2010-2012 who received either the HVAD System or an alternative LVAD approved by FDA for destination therapy in a two-to-one ratio. The ENDURANCE trial met its primary endpoint, demonstrating non-inferiority of the HVAD System to the control device; results were published in The New England Journal of Medicine.

The Medtronic portfolio of therapies, diagnostic tools and services for patients suffering from heart failure includes the industry's leading cardiac resynchronization therapy devices, including MR-conditional CRT-defibrillators and -pacemakers; mechanical circulatory support therapy for advanced heart failure patients; heart failure diagnostics; and meaningful expert analysis through Medtronic Care Management Services, including the Beacon Heart Failure Management Service.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

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