FDA Approves WorldHeart`s ePTFE Inflow Conduit for Use With the Novacor(R) LVAS
09:02 EST
/FROM CANADA NEWSWIRE OTTAWA 613-563-4465/
TO BUSINESS/FINANCIAL EDITOR:
FDA Approves WorldHeart's ePTFE Inflow Conduit for
Use With the Novacor(R) LVAS
OAKLAND, CA, Jan. 14 /PRNewswire-FirstCall/ - (OTCBB: WHRTF, TSE: WHT) -
World Heart Corporation (WorldHeart) has received approval from the U.S. Food
and Drug Administration (FDA) for an ePTFE inflow conduit as a component of
its Novacor(R) LVAS (left ventricular assist system).
The inflow conduit carries blood from the natural heart to the Novacor(R)
LVAS, which then pumps the blood into the aorta to assist a failing heart. The
conduit, which was developed by WorldHeart, utilizes expanded
polytetrafluoroethylene (ePTFE) graft material, and was previously approved
for commercial use in the European Union. The FDA has requested that
WorldHeart submit a report documenting the results of the first 20 U.S.
implants post approval.
An ePTFE conduit has been implanted with the Novacor(R) LVAS to support
86 patients in Europe and Canada. Clinical results have been highly
satisfactory, including a stroke rate reduction to single digits. "The
response of clinicians who have implanted Novacor with the ePTFE conduit has
been very positive, resulting in a significantly increased implant rate in
Europe during the past six months," said Rod Bryden, President and CEO. "We
have been anxiously awaiting FDA approval to allow us to provide this choice
to clinicians and patients in the United States," he said.
Novacor(R) LVAS is an electromagnetically driven pump that provides
circulatory support by taking over part or all of the workload of the left
ventricle. It is commercially approved as a bridge to transplantation in the
U.S. and Canada. On November 22, 2002, the FDA filed WorldHeart's Premarket
Approval (PMA) Supplement seeking destination-therapy indication for its
Novacor(R) LVAS.
In Europe, the Novacor(R) LVAS device has unrestricted approval for use
as a bridge to transplantation, an alternative to transplantation and to
support patients who may have an ability to recover the use of their natural
heart. In Japan, the device is currently 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.
Worldwide, the Novacor(R) LVAS has been implanted in more than 1400
patients. More than 90% of these patients were awaiting heart transplantation.
No deaths have been attributed to device failure, an unmatched record. More
than 300 recipients have been supported by the Novacor LVAS for greater than
6 months. Within that total, 119 recipients have been supported for more than
one year, 26 recipients for more than two years, 10 recipients for more than
three years, and 3 recipients for more than four years - statistics unmatched
by any other implanted mechanical circulatory support device on the market.
World Heart Corporation, a global medical device company based in Ottawa,
Ontario and Oakland, California, is currently focused on the development and
commercialization of pulsatile ventricular assist devices. Its Novacor(R) LVAS
(Left Ventricular Assist System) is well established in the marketplace and
its next-generation technology, HeartSaverVAD(TM), is a fully implantable
assist device intended for long-term support of patients with heart failure.
Any forward-looking statements in this release are made pursuant to the
safe harbour 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.
All financial figures are prepared in accordance with Canadian generally
accepted accounting principles (GAAP) and are expressed in Canadian dollars.
SOURCE World Heart Corporation
/CONTACT: Michelle Banning, Manager, CorporateCommunications, (510) 563-4995, or
(613) 226-4278, ext: 2995,michelle.banning@worldheart.com/ |
