News | August 27, 2008

Percutaneous ReValving System Faces Clinical Evaluation in Australia/New Zealand

August 28, 2008 - CoreValve said today 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.

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. 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.”

Several scientific presentations regarding the technology and clinical data are scheduled at the upcoming European Society of Cardiology (ESC) meeting in Munich, Germany, the company said.

CoreValve Inc., is headquartered in Irvine, CA. 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, the company said.

The CoreValve ReValving System will not be available in the U.S. for clinical trials or for sale until further notice, the company said.

For more information: www.corevalve.com

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