August 11, 2015 — HeartWare International Inc. announced that enrollment in the ENDURANCE2 destination therapy clinical trial has been completed. ENDURANCE2 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 Device (HVAD) for long-term use as destination therapy in the United States. Data from the ENDURANCE program are expected to form the basis for a pre-market approval (PMA) application seeking approval of the HeartWare System for destination therapy.
"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."
The HeartWare Ventricular Assist System features the HVAD — 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, with sintered inflow cannula, weighs approximately five ounces and displaces a volume of approximately 50 milliliters. The system received U.S. Food and Drug Administration (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.
ENDURANCE2, a supplemental cohort of HeartWare's ENDURANCE destination therapy trial, is 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 United States. 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. Food and Drug Administration (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.
In April 2015, results from the first ENDURANCE cohortwere presented at the International Society for Heart and Lung Transplantation (ISHLT) annual meeting in Nice, France. The data demonstrated that the trial successfully achieved the primary endpoint of stroke-free survival (Modified Rankin Score ≥4) at two years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery.
"We have learned a great deal since the first cohort of the ENDURANCE trial completed enrollment three years ago," said Francis D. Pagani, M.D., Ph.D., a co-principal investigator for ENDURANCE2, and surgical director of the Adult Heart Transplant Program and director of the Center for Circulatory Support at the University of Michigan Health System. "The ENDURANCE data presented at the ISHLT conference last spring reflected a learning curve, as the clinical community gained experience over time in patient care with the HeartWare System. We hope the data from this additional cohort of destination therapy patients will further that continuum of learning, so that we can continue to enhance management techniques and improve patient outcomes."
HeartWare intends to incorporate data from ENDURANCE and ENDURANCE2 in a PMA application, which HeartWare anticipates submitting to the U.S. Food and Drug Administration (FDA) next year, seeking approval of the HeartWare System for the destination therapy indication.
For more information: www.heartware.com