50 Patients Who Were Not Eligible for Open-Heart Surgery Have Now Received CoreValve's ReValving(TM) System to Non-Surgically Replace Their Diseased Aortic Heart Valve.IRVINE, Calif. and PARIS Paris, in Greek mythology Paris or Alexander, in Greek mythology, son of Priam and Hecuba and brother of Hector. Because it was prophesied that he would cause the destruction of Troy, Paris was abandoned on Mt. -- "There continue to be no device-related deaths and no device failures during implantation and at up to 14 months of follow-up. What is noteworthy is that all of these patients were considered very high risk, who would have otherwise been left untreated because they were contraindicated for the only other treatment alternative: open-heart surgery." -- Jacques Seguin, MD, PhD, Chairman, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and Founder, CoreValve CoreValve (www.corevalve.com) announced today that a total of 50 patients at seven investigative sites in Germany, Holland, Belgium and Canada have now undergone percutaneous aortic valve replacement In percutaneous aortic valve replacement (PAVR), a synthetic valve is transported to the heart through a small hole made in groin. This procedure can be compared to that performed when placing a stent, or performing balloon angioplasty. (PAVR) on a beating heart with the CoreValve Percutaneous ReValving(TM) System to treat either their aortic stenosis aortic stenosis n. Abbr. AS Pathological narrowing of the orifice of the aortic valve. Aortic stenosis A stiffening of the artery which carries blood from the heart to the body. , aortic regurgitation aortic regurgitation n. Incompetence of the aortic valve of the heart, resulting in backward flow of blood. Also called aortic insufficiency. , or failed-tissue-valve-prosthesis conditions. "One hundred percent of the patients discharged from the hospital continue to demonstrate improved cardiac function, zero long-term complications, and enjoy substantially enhanced quality-of-life at follow-up out to 14 months," said Jacques Seguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve, a cardiac surgeon who had performed some 4,000 open-heart surgeries before becoming a medical device entrepreneur. "Considering that--if left untreated--all of these individuals would have experienced a nihilistic ni·hil·ism n. 1. Philosophy a. An extreme form of skepticism that denies all existence. b. A doctrine holding that all values are baseless and that nothing can be known or communicated. 2. quality of life during their remaining time and that 25 percent of them faced the certainty of death within 12 months--we are thrilled to have been instrumental in returning these ReValving patients to a normal lifestyle where they can expect to continue enjoying time with their loved ones." Added Rob Michiels, President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of CoreValve: "Since August 2005, 36 patients have been treated with our second-generation, 21-French-sized system. The downsizing (1) Converting mainframe and mini-based systems to client/server LANs. (2) To reduce equipment and associated costs by switching to a less-expensive system. (jargon) downsizing greatly improved the ease of the procedure and, with the exclusion of prep time, the second-generation CoreValve Percutaneous ReValving System is now routinely facilitating access, delivery and placement of our porcine porcine /por·cine/ (por´sin) pertaining to swine. porcine pertaining to pig. See also hog (1), swine. porcine circovirus 1 a nonpathogenic virus. pericardial-tissue bioprosthesis in less than 15 minutes. Consequently, our accomplished investigators are scheduling two procedures during the same day. Within a few months CoreValve plans to initiate the use of our third-generation system, which has been further downsized to 18-French and is expected to bring additional procedural benefits. There can be no doubt that these technical and clinical achievements have established CoreValve as the undisputed leader in percutaneous aortic valve replacement." About CoreValve Privately held CoreValve, with U.S. headquarters in Irvine, Calif., has developed a proprietary delivery system for percutaneous heart valve replacement Heart Valve Replacement Definition Heart valve replacement is a surgical procedure during which surgeons remove a damaged valve from the heart and substitute a healthy one. , 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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