HeartWare Receives FDA Approval To Enroll Supplemental Patient Cohort In Destination Therapy Trial - Amended protocol includes enhanced blood pressure monitoring to ensure optimal patient management -
FRAMINGHAM, Mass. and SYDNEY, Aug. 27, 2013 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to commence enrollment in an additional patient cohort for ENDURANCE, the Company's pivotal, Destination Therapy clinical study.
In this supplemental cohort, HeartWare will enroll up to 286 patients receiving the HeartWare® Ventricular Assist System, as well as up to an additional 143 control patients using a randomization scheme consistent with the ENDURANCE protocol. Patients will be followed for 12 months after implant. HeartWare intends to incorporate the data from both this new cohort and ENDURANCE into an anticipated Pre-Market Approval (PMA) Application seeking approval of the HeartWare System for the Destination Therapy indication.
The protocol for this cohort is designed to confirm clinical observations that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events.
Patient enrollment can commence at the 50 centers participating in the ENDURANCE clinical trial, following Institutional Review Board approvals at each of the centers.
On November 20, 2012, FDA granted approval of the HeartWare System for the Bridge-to-Transplant indication. Concurrent with approval, the Company commenced a post-approval study (PAS) to assess device performance in a real-world setting. HeartWare's PAS is a registry consisting of 600 patients who receive an HVAD and an additional 600 control patients derived from a contemporaneous group of continuous flow, intra-corporeal LVAD patients entered into the INTERMACS database. HeartWare expects enrollment for both arms of the PAS will be complete by year's end.
About HeartWare International
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV 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 35 international 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 and the Australian Securities Exchange.
HEARTWARE, HVAD, MVAD and HeartWare logos are registered trademarks of HeartWare, Inc.
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 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 progress of clinical trials and post-approval studies, regulatory status, research and development activities and the commercial launch of the HeartWare® Ventricular Assist System in the U.S. 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. 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 further information:
HeartWare International, Inc.
Phone: +1 508 739 0864
SOURCE HeartWare International, Inc.