News:
WORLD HEART CORP - Novacor(R) LVAS Becomes Only Heart Assist Device Approved - for Japanese Market
Toronto, Ontario, Jan 04, 2002 (Market News Publishing via COMTEX) -- World Heart Corporation (WorldHeart) announced that an Import License has been granted for WorldHeart's Novacor(R) LVAS (Left Ventricular Assist System) in Japan.
WorldHeart's Novacor(R) LVAS is the only implantable ventricular assist device to receive an Import License in Japan. This completes the multi-phase process necessary for commercial sales of the system in Japan.
The Novacor(R) LVAS is distributed exclusively in Japan by Edwards Lifesciences Corporation (Edwards), which operates in that country as a joint venture entity with an affiliate of Baxter International Inc.
"We are now the only implantable heart assist device approved for commercial sale in this large untapped market," noted Roderick M. Bryden, WorldHeart President and CEO. "This Import License represents the culmination of three years of effort by WorldHeart and Edwards personnel, working closely with the various agencies in Japan." It is estimated that more than 20,000 new cases of end-stage heart disease are diagnosed in Japan each year.
Earlier this year, the companies received notification that the device had been approved by the Japanese Ministry of Health, Education, Labor and Welfare (MHLW) 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. The Import License, which is now approved, is required to permit the device to be delivered to the Japanese market.
The Novacor(R) LVAS is an implantable, pulsatile pump that takes over most of the natural heart's pumping function and delivers blood to the body, responding to the demands of the recipient's physiological state. The system includes an externally worn controller and rechargeable battery packs that allow the recipient to be discharged from the hospital and resume most normal activities.
It was designed primarily for long-term use and was the only one of four devices to successfully complete stringent testing to standards set by the National Institutes of Health (U.S.) for an implantable LVAS, exceeding the NIH reliability criteria.
To date, the Novacor(R) LVAS has been used to support more than 1300 patients in 94 centers in North America, Europe, South America, Japan and the rest of Asia. About 25 per cent of Novacor(R) LVAS recipients have been supported for at least six months. Ninety-seven recipients have been supported for more than one year, and over 20 for more than two years. The longest support duration was more than four years.
The system was approved for sale in Europe in 1994 without restriction as to the indication for use, in the United States in 1998 and later in other countries including Canada as a bridge to transplantation. The Novacor(R) LVAS is manufactured at WorldHeart's facility in Oakland, California and is distributed exclusively by Edwards in all countries outside of the United States.
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
CONTACT: TEL: (613) 226-4278 Michelle Banning, Manager
Corporate Communications, ext: 2995
EMAIL: michelle.banning@worldheart.com
TEL: (613) 226-4278 Corinna de Beer, Manager
Investor Relations, ext: 2010
EMAIL: corinna.debeer@worldheart.com
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