OAKLAND, CA, Oct. 7 /PRNewswire-FirstCall/ -- - World Heart Corporation (“WorldHeart” or the “Company”), a worldwide pioneer and technology leader in heart disease therapy, today commented on the significant increase in reimbursement for the Novacor(R) Left Ventricular Assist System (LVAS). On October 1st, 2004, the Centers for Medicare and Medicaid Services (CMS) implemented its announced increase in payment for implantation of all ventricular assist devices (VADs).
The Novacor LVAS, which was previously reimbursed under DRG 525 (diagnosis-related group), is now reimbursed under DRG 103, the highest paying DRG that covers heart transplantation procedures. This represents an increase in reimbursement to centers implanting VADs by approximately 30-40%.
Last week, CMS also announced in the Federal Register that the re- structuring of DRG 103 to include implantable VADs is “procedure driven and not based on any specific principal diagnosis”. Specifically, the Novacor LVAS, when used as a Bridge to Transplantation or for Destination Therapy in the RELIANT (Randomized Evaluation of the Novacor LVAS In A Non-Transplant Population) clinical trial, is now reimbursed under this higher paying DRG in either case.
In the U.S, WorldHeart is currently conducting the landmark clinical trial RELIANT. This Trial will evaluate the Novacor LVAS for Destination Therapy use in patients suffering from irreversible late-stage congestive heart failure who are not candidates for transplantation. Without LVAS support, these patients have a life expectancy of less than two years. Patients in the Trial will be randomly assigned to receive either the Novacor LVAS or the HeartMate(R) XVE LVAS, which was approved by the FDA in 2002 for a Destination Therapy indication. 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).
“CMS has been very responsive in reviewing the financial and clinical data for implantation of VADs and has implemented several significant reimbursement increases over the last two years. These recent increases in payment by CMS will facilitate the industry moving forward with assist devices for Destination Therapy patients who have very few options. The response from the physician and hospital communities is that these increases in CMS payment for implantation of VADs will significantly benefit enrolment in the RELIANT Trial”, commented WorldHeart President and Chief Executive Officer Jal S. Jassawalla.
About Novacor(R) LVAS:
The Novacor LVAS, a pump implanted alongside the patient’s own heart to take over a large portion of the workload of the natural heart, supports end- stage heart failure patients. It is an electrically powered, pulsatile flow device with 20 years of clinical use. The Novacor LVAS has unprecedented reliability and durability. 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. To date, more than 1,500 patients have been supported with the Novacor, with almost 600 patient years of experience, and no deaths attributable to device failure.
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 headquartered in Ottawa, Ontario, Canada, with additional facilities in 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.
Any forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including without limitation, risks in product development and market acceptance of and demand for the Corporation’s products, risks of downturns in economic conditions generally, and in the medical devices markets, risks associated with costs and delays posed by government regulation, limitations on third-party reimbursement, inability to protect proprietary technology, potential product liability and other risks detailed in the Corporation’s filings with the U.S. Securities and Exchange Commission.
WORLD HEART CORPORATION
CONTACT: Judith Dugan, Corporate Communications, World HeartCorporation, (613) 226-4278 or (510) 563-4995,communications@worldheart.com