OAKLAND, California, Oct. 28 /PRNewswire-FirstCall/ -- World Heart Corporation (“WorldHeart” or the “Company”), a worldwide pioneer and technology leader in mechanical circulatory support systems, announced today that a 60-year-old man suffering from severe heart failure became the first patient at Sacred Heart Medical Center in Spokane, Washington to receive an implanted left ventricular assist system (LVAS) in the RELIANT Trial (Randomized Evaluation of the Novacor(R) LVAS In A Non-Transplant Population). Dr. Timothy B. Icenogle and his partner Dr. David Sandler, leading cardiac surgeons, performed the procedure in this landmark RELIANT Trial.
“The RELIANT Trial is critical for the advancement of heart failure therapy for both physicians and patients alike. I’m glad to be a part of defining improved standards of care for my patients by being able to evaluate powerful alternatives for destination therapy as well as transplantation. We are delighted to give our patients the opportunity to return home and enjoy a near normal life”, commented Dr. Icenogle.
“It continues to be an exciting time for the LVAD industry and for WorldHeart. Dr. Icenogle has had a longstanding interest in the application of ventricular assist devices for destination therapy. We are pleased to partner with Dr. Icenogle and his outstanding team at Sacred Heart to offer the benefits of the RELIANT Trial to their patient population”, added Mr. Jal S. Jassawalla, WorldHeart President and CEO.
About the RELIANT Trial:
The RELIANT Trial will evaluate the Novacor LVAS for Destination Therapy use by patients suffering from irreversible left ventricular failure who are not candidates for transplantation. Recipients will be randomized, on a 2:1 basis, to receive the Novacor LVAS or the HeartMate(R) XVE LVAS.
The objective of the Trial is to demonstrate that use of Novacor LVAS is superior to optimal medical therapy by demonstrating equivalence to HeartMate XVE LVAS, which has been evaluated and approved for such use. Novacor LVAS has Category B status under the existing IDE that permits reimbursement by the Centers for Medicare and Medicaid Services (CMS) for implants within the Trial. Data from this Trial is expected to support a Pre-market Approval Supplement that will request approval for use of the Novacor LVAS by non- transplant eligible patients (Destination Therapy).
About Novacor(R) LVAS:
The Novacor LVAS is an electrically powered, pulsatile flow device with more than 20 years of clinical use. It is the first ventricular assist device to provide a recipient with more than 6 years of circulatory support and continues to hold the industry record for longest support on a single device, over 4 years; statistics unmatched by any other implanted electromechanical circulatory support device on the market. To date, more than 1,500 patients have been supported by the Novacor LVAS.
The Novacor LVAS is commercially approved as a bridge to transplantation in the U.S. and Canada. In Europe, the Novacor LVAS has unrestricted approval for use as an alternative to transplantation, a bridge to transplantation, and to support patients who may have an ability to recover the use of their natural heart. In Japan, the device is commercially approved for use in cardiac patients at risk of imminent death from non-reversible left ventricular failure for which there is no alternative except heart transplantation.
About World Heart Corporation:
World Heart Corporation is a global medical device company with offices in Ottawa, Ontario, Canada, Oakland, California, USA and Heesch, Netherlands. WorldHeart is currently focused on the development and commercialization of pulsatile ventricular assist devices. Its Novacor LVAS is well established in the marketplace and its next-generation technology is a miniaturized implantable assist device building on the proven Novacor technology.
WORLD HEART CORPORATION
CONTACT: World Heart Corporation, Judith Dugan, (501) 563-4995,http://www.worldheart.com/