Let's cross our fingers and hope this is it for delays prior to human trials...
WorldHeart Resumes HeartSaverVAD Pre-Clinical Trials: On Track for Human Study Later this Year
OTTAWA, Apr 17, 2002 /PRNewswire-FirstCall via COMTEX/ -- (NASDAQ: WHRT, TSE: WHT) - World Heart Corporation (WorldHeart) today announced that the final series of animal trials for HeartSaverVAD(TM) resumed this week with two implants at U.S. centers. Ten (10) additional implants are planned over the next several weeks. These implants will conclude the in vivo pre-clinical trials. This data will support application for a clinical trial expected to begin in Canada in the fourth quarter of this year.
The HeartSaverVAD(TM) pre-clinical trial program was interrupted in December, 2001 after testing was conducted with 17 animals for durations of 13 to 91 days. Those tests showed excellent results in pathology, biocompatibility and device performance. Irregularities in electrical and data flow through implanted cables and connectors required significant enhancements in design and manufacturing processes of these components to ensure reliability and durability.
"HeartSaverVAD(TM) has demonstrated excellent in vivo results throughout the in vivo trial program," Dr. Tofy Mussivand, Chairman and Chief Scientific Officer of WorldHeart, said. "It has been disappointing to be delayed in completing these trials as a result of the need for improvements in the internal cables and connectors. However, we are pleased to now be able to proceed with the final steps needed to bring HeartSaverVAD(TM) to clinical trials," he said.
HeartSaverVAD(TM) is a pulsatile left ventricle assist device, designed to be fully implanted in the chest to deliver part or all of the pumping action of the left ventricle for life-long use by patients with heart failure. The device responds to the body's changing demand for blood just as the natural heart does, and delivers a pulse of blood with each beat, mirroring the natural heart. HeartSaverVAD(TM) will leave no permanent openings in the skin or tissue and can be remotely powered, monitored and controlled using the patented Transcutaneous Energy Transfer (TET) and proprietary biotelemetry technologies. Recipients are expected to leave the hospital and resume near normal day-to-day activities.
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 already 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 |
