Healthcare Industry News: TandemHeart
News Release - July 12, 2006
CoreValve reports new milestone: ReValving(TM) procedures are performed (a) without extracorporeal bypass, (b) without respiratory assistance, and (c) without intubation and full anesthesia"With our imminent transition to an 18-French system and the anticipated continued use of temporary percutaneous left ventricular assist devices for unloading the heart, our entire ReValving procedure can now be a truly percutaneous alternative to open-heart surgery for replacing a diseased aortic heart valve."
- Jacques Seguin, MD, PhD, Chairman, CEO and Founder, CoreValve
IRVINE, Calif.--(HSMN NewsFeed)--July 12, 2006--CoreValve (www.corevalve.com) announced today that cardiologists in Europe and Canada continue the validation of the CoreValve ReValving(TM) System as a truly non-surgical approach to aortic valve replacement. The latest progress was made possible by using CardiacAssist's TandemHeart® PTVA® System, a percutaneous left ventricular assist device (LVAD) that helps to unload the beating heart and assures continuous, naturally oxygenated blood circulation through a simple trans-septal catheterization procedure. The CardiacAssist device has received regulatory clearances in Europe and the U.S.
The first ReValving procedures using the CardiacAssist device were performed by Professor Patrick W. Serruys and Dr. Peter DeJaegere at Erasmus University Medical Center, Rotterdam, the Netherlands, and by Dr. Raoul Bonan at the Montreal Heart Institute, Quebec, Canada.
"The significance of these latest ReValving procedures is that they are the first to eliminate the need for a cut-down for fem/fem extracorporeal bypass, while retaining the cardiac support safety factor for the patient. By taking advantage of the CardiacAssist TandemHeart PTVA System technology, a purely percutaneous ReValving procedure is now possible," said Jacques Seguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve. "This development catapults CoreValve further into the technology lead in the percutaneous aortic valve replacement (PAVR) sector."
Added Rob Michiels, President and COO of CoreValve: "In essence, the TandemHeart PTVA System functions with the patient's own right heart and lungs to provide the equivalent of full cardiac bypass, and we are pleased to have this minimally invasive circulatory support system available so that our breakthrough ReValving procedure can be done safely and efficiently in the cath lab."
Founded in 1996, CardiacAssist is a privately held, Pittsburgh-based medical device company that develops, manufactures and markets innovative products designed to provide cardiologists and cardiac surgeons with minimally invasive solutions for treating weakened and failing hearts. Its vision is to help advance the treatment of heart disease by bridging gaps in current treatment methodologies. For more information about CardiacAssist, visit the Company's website at www.TandemHeart.com.
Privately held CoreValve, with U.S. headquarters in Irvine, Calif., has developed a proprietary delivery system for percutaneous heart valve replacement, based on a novel catheter-and-self-expanding-frame approach on a beating heart, thus avoiding open-heart surgery. The CoreValve procedure--with the proprietary CoreValve ReValving(TM) System--can be performed in a cardiac 'cath lab' just like angioplasty and stenting, resulting in less trauma to the patient and substantial cost-savings to the healthcare system. For more information about CoreValve, visit the Company's Web site at www.corevalve.com.
This news release contains certain "forward-looking" statements under the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of CoreValve, are based on management's current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the protection of intellectual property, changes to governmental regulation of medical devices, the FDA's approval of new products, the impact of competitive products, changes to the competitive environment, the acceptance of new products in the market, conditions of the interventional cardiology industry and the economy and other factors.
The CoreValve ReValving(TM) System will not be available in the USA for clinical trials or for commercialization until further notice.
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