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Devices Cardiology

 News Release - January 7, 2008

CoreValve announces that more than 500 high-risk patients have been treated with its ReValving(R) System for percutaneous aortic valve replacement (PAVR)

Company's 18-French ReValving(R) System, which received European regulatory clearance in mid-2007, is the smallest PAVR system in the clinic

IRVINE, Calif.--(HSMN NewsFeed)--CoreValve ( announced today that the expanded clinical evaluation of its ReValving® System for percutaneous aortic valve replacement (PAVR) in high-risk patients with aortic stenosis is enrolling patients at 32 sites in 11 European countries. The ReValving® System procedures can be performed under local anesthesia, without the need for surgical cut-down/repair, and without hemodynamic support or artificially accelerating the heart rate.

Clinical results to date not only underscore the acute procedural benefits of PAVR for high-risk and inoperable patients, but also demonstrate the potential for reduced hospital stays and for high quality-of-life patient outcomes. The ReValving® System bioprosthesis, which was specifically designed for transcatheter delivery, now has positive follow-ups out to nearly three years in this octogenarian patient population.

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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