Australia/New Zealand Regulatory-Cleared Evaluation Registry is Expected to Lead to Market Clearance for These Countries

IRVINE, Calif. (Business Wire EON/PRWEB ) August 28, 2008 -- CoreValve (www.corevalve.com) announced today that an Australia/New Zealand-focused clinical evaluation of its proprietary percutaneous ReValving® System, which features a porcine pericardium valve mounted in a self-expanding frame, was initiated last week.

With the CoreValve ReValving system, a new heart valve can be implanted from a small hole made in the groin, and therefore there is no need for major surgery or an incision in the chest

Patient recovery is much quicker, and the procedure can be performed on patients who are at very high risk, or not candidates, for traditional heart valve surgery. This procedure is truly a revolution in cardiology and is part of the trend toward less-invasive treatment

Currently, percutaneous aortic valve replacement (PAVR) is used for carefully selected high-risk patients only. But if good long-term results are sustained, PAVR may substitute for traditional aortic valve replacement surgery in more patients.

The first four procedures using the CoreValve ReValving® System were performed in two days by John Ormiston, M.D., Medical Director at Mercy Hospital in Auckland, New Zealand.

“With the CoreValve ReValving system, a new heart valve can be implanted from a small hole made in the groin, and therefore there is no need for major surgery or an incision in the chest,” said Dr. Ormiston. “Patient recovery is much quicker, and the procedure can be performed on patients who are at very high risk, or not candidates, for traditional heart valve surgery. This procedure is truly a revolution in cardiology and is part of the trend toward less-invasive treatment,” added Dr. Ormiston. “Currently, percutaneous aortic valve replacement (PAVR) is used for carefully selected high-risk patients only. But if good long-term results are sustained, PAVR may substitute for traditional aortic valve replacement surgery in more patients.”

“We are gratified by the continued clinical acceptance of our ReValving technology, the smallest percutaneous system currently available. The extensive clinical experience we have in Europe, where we are the market leader, will greatly facilitate the introduction of our revolutionary technology in the Pacific Rim and other regions throughout the world. Additionally, several scientific presentations regarding our technology and clinical data are scheduled at the upcoming European Society of Cardiology (ESC) meeting in Munich, Germany,” said Daniel Lemaitre, CoreValve’s President and Chief Executive Officer.

About CoreValve

CoreValve, Inc., is headquartered in Irvine, Calif. Its proprietary ReValving® System allows both percutaneous aortic valve replacement (PAVR) and transapical aortic valve replacement (TAVR) and is intended to provide an alternative to open-heart surgery. The ReValving System procedures are performed on the beating heart without cardiac assistance or rapid pacing, and may result in less trauma to the patient. This technology may also offer substantial cost-savings to the healthcare system. The catheter-based technology includes a proprietary framed/self-expanding tissue heart valve that is specifically designed and engineered for transcatheter delivery. For more information about CoreValve, visit the Company’s Web site at www.corevalve.com.

(Caution: the CoreValve ReValving System will not be available in the USA for clinical trials or for sale until further notice.)

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percutaneous aortic valve replacement valve replacement revalving heart surgery corevalve

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