Enrollment in HeartWare International’s ENDURANCE2 destination therapy clinical trial has been completed. Data from the ENDURANCE trial program are expected to form the basis for a Pre-Market Approval (PMA) Application seeking approval of the HeartWare System for destination therapy.
HeartWare International, Inc. is a leading innovator of less invasive, miniaturized circulatory support technologies.
The HeartWare® Ventricular Assist System features the HVAD Pump, a small, full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HVAD Pump, with sintered inflow cannula, weighs approximately five ounces and displaces a volume of approximately 50ml. The HeartWare Ventricular Assist System received FDA approval in 2012 as a bridge to heart transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
The HeartWare System is currently the leading ventricular assist device implanted in patients outside of the United States, having received CE Marking in the European Union in 2009 and Australian Therapeutic Goods Administration (TGA) approval in 2011. Today, more than 9,000 advanced heart failure patients globally have received the HVAD Pump.
Its ENDURANCE2 trial is the largest destination therapy clinical trial of a ventricular assist device conducted to date and is designed to evaluate patients implanted with the HeartWare® Ventricular Assist System for long-term use as destination therapy in the United States. ENDURANCE2 is a supplemental cohort of HeartWare’s ENDURANCE destination therapy trial, a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with an HVAD® Pump who receive optimal blood pressure management. The study was designed to enroll 465 patients at one of the 50 participating hospital centers in the U.S. Patient enrollment occurred between October 2013 and August 2015, and patients were randomly selected to receive either the HeartWare Ventricular Assist System or, as part of a control group, any alternative left ventricular assist device (LVAD) approved by the U.S. FDA for destination therapy, in a 2:1 ratio. The primary endpoint of the trial is incidence of neurologic injury at 12 months on the originally implanted device, and the endpoint will be tested for non-inferiority versus the control device.
“This trial supports our commitment to studying enhanced patient management strategies and identifying best practices for patients who receive the HeartWare System,” said Joseph Rogers, M.D., interim chief of the Division of Cardiology at Duke University, and a co-principal investigator for ENDURANCE2. “Optimizing patient care is a critical component of our ongoing focus to improve patient outcomes with mechanically assisted circulation.”
“We are delighted to have completed enrollment in this important study and would like to thank the investigators, coordinators and entire heart team at each hospital site for participating in this trial and for focusing on improved patient management,” said Doug Godshall, President and CEO at HeartWare. “This second phase of our destination therapy trial reflects HeartWare’s commitment to research and to the betterment of patient outcomes.”
Source: PR Newswire