The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The panel agreed unanimously (11-0) that the new device is effective. The panel was more divided about safety but ultimately voted 8-3 that the device was safe.
In briefing documents published online earlier in the week, FDA reviewers raised a number of questions about the safety of the device and the reliability of the data from the pivotal ADVANCE trial, in which 140 patients received the Heartware device and were compared to historical controls who had received Thoratec’s HeartMate II device. The FDA had not previously permitted historical controls to be used in this fashion. Safety questions focused on stroke and thrombosis.
Unlike the HeartMate II VAS, which is surgically implanted in an abdominal pouch, the HeartWare VAS is implanted next to the heart.
“I think this device is of incredible benefit to patients who are very ill,” said panelist Ralph Brindis, as reported by MedPage Today. Acting panel chair Rick Page said the device represented “a real advance in technology,” as reported by Heartwire.
Here is the press release from HeartWare:
FDA Advisory Committee Votes in Favor of HeartWare® Ventricular Assist System as Bridge to Transplant for Patients With End-Stage Heart Failure
FRAMINGHAM, Mass. and SYDNEY, April 25, 2012 /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’s (FDA) Circulatory System Devices Advisory Committee voted 9 to 2 that the benefits outweigh the risks for the use of the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.
“We are pleased with the panel’s strong recommendation and would like to thank them for their thoughtful review of the data presented from the ADVANCE study,” said Doug Godshall, CEO and President of HeartWare. “The Advisory Committee meeting outcome represents an important step toward approval of the HeartWare® Ventricular Assist System in the United States, and we look forward to continuing our dialogue with the FDA as it finalizes its review of our PMA. HeartWare remains committed to optimizing outcomes for patients with end-stage heart failure and looks forward to expanding the clinical experience for the device in the future.”
The Advisory Committee’s recommendation, while not binding, will be considered by the FDA in its review of the Premarket Approval (PMA) application that HeartWare submitted for the HeartWare® Ventricular Assist System in December 2010.
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-output circulatory support device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HeartWare System has received CE Marking in the European Union and TGA approval in Australia. The device is currently the subject of United States clinical trials for two indications: destination therapy and bridge-to-transplant under a continued access protocol. 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.
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 timing and progress of, and presentation of data related to, clinical trials, expected timing of regulatory filings and approvals, and research and development activities. 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, the possibility the FDA does not approve the marketing of the HeartWare® Ventricular Assist System in the U.S., and those described in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission. We may update our risk factors from time to time in Part II, Item 1A “Risk Factors” in our 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.
Web Site: http://www.heartware.com