CoreValve, S.A. Seeks IRB Approval for World's First Human Implantation of Its 'Self-Expanding Stented Heart Valve'.Business Editors/Health/Medical Writers PARIS--(BUSINESS WIRE)--May 19, 2004 CoreValve's Breakthrough ReValving(TM) Device Will Provide Preferred Alternative to Open-Heart Surgery Company to Show Its Patented Device for the First Time at "EuroPCR" Cardiovascular Congress in Paris, May 25-28, 2004: Exhibit "N1 IET IET Institution of Engineering and Technology (merged name of IEE and IIE) IET Initial Entry Training IET Image Enhancement Technology IET Institute of Environmental Technology (Houston, TX) " in Neuilly Hall CoreValve, S.A., an emerging and privately held medical technology company, announced today that it is seeking Institutional Review Board (IRB IRB See: Industrial Revenue Bond ) approval from two undisclosed medical institutions related to its proprietary and revolutionary self-expanding stented heart valve, to be implanted in a human, for the first time, using the CoreValve Percutaneous ReValving(TM) System in a cardiac catheterization Cardiac Catheterization Definition Cardiac catheterization (also called heart catheterization) is a diagnostic procedure which does a comprehensive examination of how the heart and its blood vessels function. ("cath") laboratory. It is expected that the patient selected will be able to avoid open-heart surgery to treat 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. , a narrowing of the heart valve. The first-of-its-kind procedure on a human is expected to be performed next month. "We believe CoreValve is redefining the way 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. will be performed in the future," said Dr. Jacques Seguin, chairman and co-founder of CoreValve. "We look forward to unveiling our technology at EuroPCR next week." Aortic stenosis is a narrowing of the heart valve that causes the heart to work very hard in order to eject blood from the ventricle ventricle /ven·tri·cle/ (ven´tri-k'l) a small cavity or chamber, as in the brain or heart.ventric´ular ventricle of Arantius the rhomboid fossa, especially its lower end. , resulting in shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. and, in advanced cases, in fainting and heart failure. Today, symptomatic patients are typically treated by open-heart surgery. More than 300,000 patients every year have surgery on their heart valves Heart valves Valves that regulate blood flow into and out of the heart chambers. Mentioned in: Heart Failure . Sixty percent of valve replacement surgeries are for the aortic valve aortic valve n. The valve between the left ventricle of the heart and the ascending aorta, consisting of three semilunar cusps. Aortic valve . About CoreValve, S.A. Privately held CoreValve, headquartered in Paris, has developed a universal system for percutaneously replacing a defective aortic valve, based on a catheter delivery system and self-expanding-stent approach on a beating heart, thus avoiding open-heart surgery. The CoreValve Percutaneous ReValving(TM) System can be adapted to any biological valves currently marketed or synthetic valves when approved. The CoreValve procedure 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. This news release contains certain "forward-looking" statements, which are based on management's current expectations 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 regulatory 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 other factors. |
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