Healthcare Industry News: self-expanding
News Release - October 20, 2006
CoreValve announces successful completion of world's first 'pure' percutaneous aortic valve replacement (PAVR) procedure utilizing its patented ReValving(TM) system
"This first-ever, pure PAVR procedure, requiring no surgical cut-down, on a 'high risk' patient--89 years old and too frail for open-heart surgery--offers additional unmistakable confirmation that our ReValving approach to percutaneous aortic valve replacement is progressing quickly toward becoming the future alternative to open-heart surgery."Jacques Seguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve
IRVINE, Calif.--(HSMN NewsFeed)--CoreValve (www.corevalve.com) announced today that its patented ReValving System, consisting of a breakthrough 18-French-sized delivery catheter, was used to percutaneously implant its proprietary porcine pericardial-tissue bioprosthesis over the severely calcified aortic heart valve of an 89-year-old female patient. In contrast to long post-surgical recuperation times, this 'pure' PAVR patient was discharged from the ICU to the general ward on the morning after her ReValving procedure and was fully mobile and awaiting discharge from the hospital.
The successful procedure was performed at Erasmus University Medical Center, Rotterdam, The Netherlands, by Professor Patrick W. Serruys and Dr. Peter DeJaegere, globally recognized interventional cardiologists who have been leading investigators in clinical trials of numerous cutting-edge technologies.
"Thousands of critically ill patients with severe aortic valve stenosis are refused surgery every year, and the annual mortality rate is as high as 25 percent in this frail population," said Prof. Serruys. "I believe that ReValving can give these patients a truly percutaneous option performed by the interventional cardiologist in the cath lab." Added Dr. DeJaegere: "The fact that the ReValving delivery catheter has been reduced in size to 18-French not only makes maneuverability and general handling of the ReValving system superior to previous-generation devices. It has made a true percutaneous femoral access possible and also a true and complete percutaneous procedure when using p-LVAD support during the implantation."
"To date, the ReValving patients who have been discharged from the hospital continue to demonstrate improved cardiac function, absence of long-term complications, and dramatically enhanced quality-of-life at follow-up out to more than 14 months (mean: 6.9 months)," said Jacques Seguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve. "Our swift technological advancements are the outcome of a strategy that concentrated on a breakthrough design for a bioprosthesis dedicated to a purely percutaneous application. With this latest clinical achievement, we have demonstrated that aortic valve replacement is no longer restricted to surgical or transcatheter options, and we have further entrenched CoreValve as the indisputable front-runner in this new interventional frontier. We continue to believe we are on schedule to secure a CE Mark and first-to-market position for our ReValving System in Europe next year."
About CoreValve
Founded in 2001, privately held CoreValve--which is headquartered in Irvine, California--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 Percutaneous 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.
Forward-Looking Statements
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.
(Caution: the CoreValve ReValving(TM) System will not be available in the USA for clinical trials or for commercialization until further notice. Non-USA clinical investigations are in progress. Not available for sale.)
Source: CoreValve
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