First Percutaneous Aortic Valve Replacement (PAVR) Procedure without Any Cardiac Support (i.e., Mechanical Assistance or Accelerated Pacing) Performed with CoreValve's Non-Surgical ReValving(TM) System."This milestone is as important for the CoreValve ReValving technology as the first-ever procedure waseI|not only because it avoided open-heart surgery for these very frail patients, but also because these uneventful procedures were performed in a cath lab without the use of extracorporeal extracorporeal /ex·tra·cor·po·re·al/ (-kor-por´e-al) situated or occurring outside the body. ex·tra·cor·po·re·al adj. Situated or occurring outside the body. bypass, or cardiac assistance, or even rapid pacing. ReValving is rapidly becoming very similar to a routine cath lab intervention." Jacques S[R] guin, M.D., Ph.D., 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 of CoreValve IRVINE, Calif. -- 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 porcine /por·cine/ (por´sin) pertaining to swine. porcine pertaining to pig. See also hog (1), swine. porcine circovirus 1 a nonpathogenic virus. pericardial pericardial /peri·car·di·al/ (-kahr´de-al) 1. pertaining to the pericardium. 2. surrounding the heart. pericardial pertaining to the pericardium. tissue bioprostheses over the severely calcified Calcified Hardened by calcium deposits. Mentioned in: Heart Valve Repair aortic aortic pertaining to or emanating from the aorta. See also aortic arch. aortic aneurysm occurs most often in dogs, where it is caused by Spirocerca lupi larvae, turkeys and primates, causing dyspnea, cyanosis and coughing. heart valves of an 88-year-old female patient and a 77-year-old male patienteI|without the use of extracorporeal bypass, other cardiac assistance or even rapid pacing. These first-ever medical-milestone procedures took routine interventional times to complete, and the patients were released from the ICU ICU intensive care unit. ICU abbr. intensive care unit ICU see intensive care unit. ICU within hours of the completion of the ReValving procedure and are awaiting discharge from the hospital. The successful procedures were performed at the HELIOS Heart Center (HHC HHC Home Health Care HHC Headquarters Company HHC Health and Hospitals Corporation (New York, NY) HHC Hand-Held Computer HHC Hiphopcanada Inc. ), Siegburg, Germany, by Eberhard Grube, M.D., Chief of Cardiology and Angiology angiology /an·gi·ol·o·gy/ (an?je-ol´ah-je) the study of the vessels of the body; also, the sum of knowledge relating to the blood and lymph vessels. an·gi·ol·o·gy n. at HHC and a consulting professor of medicine at Stanford University. "Since we performed the very first cases two years ago, ReValving continues to evolve toward a simple and straightforward cath lab procedure," said Dr. Grube. "The clinical investigators are gradually eliminating those procedural elements that are less conducive to the cath lab setting, and I commend the Company and its Scientific Advisory Board for designing study protocols that allow for procedural progress without compromising patient safety. As the clinical experience in Europe and North America now approaches 100 cases, there is no question in my mind that many patients in the future will be able to have their diseased aortic heart valve replaced percutaneously in a cath lab rather than having to endure open-heart surgery." "This latest clinical accomplishment substantiates our conviction that aortic valve replacement Aortic valve replacement is a cardiac surgery procedure in which a patient's aortic valve is replaced by a different valve. The aortic valve can be affected by a range of diseases; the valve can either become leaky (aortic insufficiency / regurgitation) or partially blocked (aortic is no longer limited to surgical or mere transcatheter alternatives and fortifies CoreValveeIUs position as the undeniable leader in truly percutaneous valve replacement. We continue to work hard toward earning a CE Mark and first-to-market position for our ReValving System in Europe," said Jacques S[R] guin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve. About CoreValve Founded in 2001, privately held CoreValveeI|which is headquartered in Irvine, CaliforniaeI|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 procedureeI|with the proprietary CoreValve Percutaneous ReValvinge SystemeI|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 CompanyeIUs 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 managementeIUs 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 FDAeIUs 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 ReValvinge 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.) |
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