Healthcare Industry News:  self-expanding 

Devices Cardiology

 News Release - September 8, 2008

CoreValve Announces Successful Completion of Initial Series of Proctored Cases in Australia and New Zealand Using Its ReValving(R) System for Percutaneous Aortic Valve Replacement

CoreValve to present clinical data at "22nd EACTS Annual Meeting" in Lisbon, Portugal

IRVINE, Calif.--(HSMN NewsFeed)--CoreValve ( announced today that five (5) clinical evaluation sites—two in New Zealand and three in Australia—have now completed their first series of proctored cases using the Company’s proprietary ReValving® System for percutaneous aortic valve replacement (PAVR), which features a porcine pericardium valve mounted in a self-expanding frame.

During a 12-day period, 24 patients at hospitals in Auckland, Brisbane, Melbourne, Sydney and Hamilton underwent successful percutaneous aortic valve replacement with CoreValve’s ReValving System. These hospitals are participating in a clinical evaluation registry as required for market clearance in Australia and New Zealand. To date, more than 1,500 patients at 75 sites worldwide have now received a ReValving bioprosthesis since the CE Mark was issued. Physicians will be presenting CoreValve clinical data at the “22nd EACTS (European Association for Cardio-Thoracic Surgery) Annual Meeting” in Lisbon, Portugal, which begins September 13th.

“We are gratified to see tremendous enthusiasm for our ReValving technology in Australia and New Zealand,” said Daniel Lemaitre, President and Chief Executive Officer of CoreValve. “More importantly, the clinical results generated by these pioneering centers are remarkable and a testimony to the ability to leverage the extensive European clinical experience that has catapulted us into the leadership position in the transfemoral aortic valve replacement market.”

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

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

Source: CoreValve

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