From the Wires
HeartWare Receives FDA Approval for HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation for Patients with Advanced Heart Failure
By: PR Newswire
Nov. 20, 2012 03:01 PM
– First full-support, miniaturized ventricular assist device approved in U.S. designed to be placed in the pericardial space –
– HeartWare Management to Host Investor Conference Call Today at 3:00 pm ET –
FRAMINGHAM, Massachusetts and SYDNEY, Nov. 20, 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 it has received approval from the United States Food and Drug Administration (FDA) for the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.
The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-support circulatory assist device (up to 10L/min flow) 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 5 ounces and displaces a volume of approximately 50 milliliters. The HeartWare System is intended for use as a bridge to cardiac 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 2,500 advanced heart failure patients globally have received the HVAD® pump.
"FDA approval marks the culmination of an extensive clinical effort and represents an exciting advance in the treatment of late-stage heart failure patients," said Doug Godshall, President and Chief Executive Officer of HeartWare. "We wish to extend our most sincere thanks to the patients, and to their families, for participating in the study of this innovative device, and we also are grateful to each of the nurses, coordinators, surgeons and cardiologists who provided care to those patients."
Achieving long-standing goals
HeartWare's pre-market approval (PMA) submission included data from the Company's pivotal ADVANCE clinical trial, an FDA approved Investigational Device Exemption (IDE) study designed to evaluate the HeartWare System as a bridge to heart transplantation for patients with end-stage heart failure. Under ADVANCE, 140 patients at 30 hospitals in the U.S. received the HeartWare investigational device between August 2008 and February 2010. The ADVANCE study achieved a 94% survival at 6 months and successfully met its primary endpoint of establishing non-inferiority between the investigational device and comparator arm of the study, which was derived from contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) [p<0.0001]. Four supplemental allotments of patients have been granted by the FDA under a Continued Access Protocol (CAP), encompassing more than 250 additional patients.
To help assure the continued safety and effectiveness of an approved device, FDA requires a post-approval study (PAS) as a condition of approval under 21 CFR 814.82(a)(2) 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. The data for both arms of the study will be entered into the INTERMACS registry by the implanting centers. Other post approval commitments include the transfer of patients from the ADVANCE IDE study into a post approval database as well as an obligation to continue training sites in accordance with an approved training program.
In other clinical development for the HeartWare Ventricular Assist System, HeartWare has completed enrollment of a 450-patient destination therapy study at 50 U.S. sites. The final patients were implanted in May 2012, with a two-year, primary endpoint follow-up period. HeartWare has requested a Continued Access Protocol allocation for destination therapy from the FDA.
A live webcast of the call will also be available at the Company's website (www.heartware.com) by selecting "HeartWare FDA Approval Conference Call" under the section titled "Corporate Presentations" on the Home Page. A replay of the conference call will be available through the above weblink immediately following completion of the call.
About HeartWare International
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.
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