FRAMINGHAM, Mass., Aug. 10, 2015 /PRNewswire/ -- HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today 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 System 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."
"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."
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 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. 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.
ENDURANCE Destination Therapy Trial: Primary Endpoint Met In April 2015, results from the first HeartWare Ventricular Assist System destination therapy clinical trial cohort, ENDURANCE, were presented at the International Society for Heart and Lung Transplantation (ISHLT) annual meeting in Nice, France. The data presented 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's ENDURANCE clinical trial is a prospective, randomized, controlled, unblinded Investigational Device Exemption (IDE) study designed to evaluate the HeartWare Ventricular Assist System as a destination therapy for patients with end-stage heart failure who are ineligible for heart transplantation. Between August 2010 and May 2012, 446 patients were enrolled at 48 hospital centers in the U.S. and were randomly selected to receive either the HeartWare Ventricular Assist System or, as part of a control group, any alternative LVAD approved by FDA for destination therapy, in a 2:1 ratio.
HeartWare intends to incorporate data from ENDURANCE and ENDURANCE2 in a PMA application, which HeartWare anticipates submitting to FDA next year, seeking approval of the HeartWare System for the destination therapy indication.
HeartWare® Ventricular Assist System 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 50 milliliters. 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.
About HeartWare International HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure. 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 HeartWare System is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, has received CE Marking in the European Union and has been used to treat patients in 46 countries. The device is also currently the subject of a U.S. clinical trial for destination therapy. For additional information, please visit the Company's website at www.heartware.com.
HeartWare International, Inc. is a member of the Russell 2000® and its securities are publicly traded on The NASDAQ Stock Market.
HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates.
Forward-Looking Statements This announcement contains forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the: commercialization of the HeartWare® Ventricular Assist System; timing, progress and outcomes of clinical trials; regulatory and quality compliance; research and development activities and our ability to take advantage of acquired and pipeline technology. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by federal securities laws and the rules and regulations of the Securities and Exchange Commission. HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation those described in Part I, Item 1A. "Risk Factors" in HeartWare's Annual Report on Form 10-K filed with the Securities and Exchange Commission. HeartWare may update risk factors from time to time in Part II, Item 1A "Risk Factors" in Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, or other filings with the Securities and Exchange Commission.
For additional information: Christopher Taylor HeartWare International, Inc. Email: email@example.com Phone: +1 508 739 0864
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