Proven stop gap measure from a home town firm, until someone comes up with a way to strengthen the heart muscle and clean out the pipes (assuming other organs in good working order),...
WorldHeart announces medical milestone surgeons implant 1500th Novacor(R) LVAS
OAKLAND, CA, Jan. 12 /CNW/ - (OTCBB: WHTOF, TSX: WHT) - World Heart
Corporation (WorldHeart or the Company) today announced that a heart-failure
patient in Germany became the 1500th recipient of a Novacor(R) LVAS (left
ventricular assist system). O.A. Dr. Latif Arusoglu, Department for Thorax and
Heart Surgery at the Heart and Diabetes Center in Bad Oeynhausen, Germany
carried out the implant.
"We have implanted more than 100 Novacor LVAS devices at our clinic to
support patients who would otherwise be at very high risk of death due to
heart failure. We have been very pleased with the results for our patients and
expect an increasing rate of use of Novacor in 2004. This 1500th patient is
doing well after the implant and we expect the patient to return home in the
next few days," said O.A. Dr. Aly El-Banayosy, Department for Thorax and Heart
Surgery at the Heart and Diabetes Center in Bad Oeynhausen, Germany.
Roderick M. Bryden, WorldHeart's President and CEO, commented on this
significant milestone: "The medical team in Bad Oeynhausen is an important
part of the nearly two-decade clinical history of the Novacor LVAS, having
implanted more than 100 of these devices at their prestigious center. There
have been no recipient deaths attributed to device failure in 1,500 implants
to date. Our data for the Novacor LVAS demonstrates a significant survival
benefit, well-characterized efficacy, and unmatched multi-year reliability and
durability."
More than 90% of the 1,500 Novacor LVAS devices implanted were intended
to support the recipient until a donor heart was available for
transplantation. Novacor LVAS has an industry-leading record for reliability
and durability with one recipient supported for close to six years, three for
over four years, 14 for over three years, 35 for over two years, and 131 for
over one year - statistics unmatched by any other implanted electromechanical
cardiac assist device on the market.
About 550,000 new cases of congestive heart failure are diagnosed in the
United States each year, five million Americans already have the condition,
and there are fewer than 2,500 available donor hearts. Heart failure, the
heart's inability to pump enough blood through the body, is directly
responsible for almost 53,000 deaths annually and is a contributing factor in
the deaths of approximately another 215,000 Americans, according to the
National Heart, Lung, and Blood Institute. "Supply will never out pace the
demand for donor hearts therefore it is necessary to find long-term
alternatives to transplantation to help extend the lives of the millions of
people suffering from heart failure," stated Mr. Bryden.
WorldHeart recently announced that, subject to approval by the Food and
Drug Administration (FDA) it intends, to conduct a Pivotal Trial in
approximately 40 centers in the United States, in which Novacor LVAS will be
compared to Thoratec Corporation's HeartMate(R) XVE LVAS (left ventricular
assist system) for use as Destination Therapy in patients suffering from
irreversible left ventricular failure who are not transplant candidates.
In the United States, the FDA is currently reviewing WorldHeart's Pre-
Market Approval Supplement submission to expand the current indication for
Novacor LVAS to include implants in end-stage heart failure patients who have
relative contraindications that may resolve with LVAS support.
About Novacor(R) LVAS
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Novacor LVAS is an implanted electromagnetically driven pump that
provides circulatory support by taking over part or all of the workload of the
left ventricle. With implants in 1,500 patients, no deaths have been
attributed to device failure, and some recipients have lived with their
original pumps for as long as four years - statistics unmatched by any other
implanted mechanical circulatory support device on the market.
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 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 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. |
