The News

CoreValve announces that more than 1,000 high-risk patients have been treated with its ReValving® System for percutaneous aortic valve replacement (PAVR)

15/05/2008

Highly encouraging registry data also presented at EuroPCR 2008

IRVINE, Calif., May 15, 2008—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 continues to enroll patients at an accelerating pace.  These procedures can be performed under local anesthesia, without the need for surgical cutdown/repair, and without hemodynamic support or artificially accelerating the heart rate.

Also at the meeting, Maurice Buchbinder, MD (San Diego, Calif.), and Patrick Serruys, MD, PhD (Rotterdam, The Netherlands) presented clinical data from the ongoing post-CE Mark expanded clinical evaluation registry at the EuroPCR 2008 cardiovascular intervention meeting taking place in Barcelona, Spain. One-month post-procedure, 92 percent of the high-risk and often inoperable octogenarian patients were alive and well and only nine percent needed subsequent pacemaker implantation. Quality-of-life improvements endured in patients followed up to six months.

“We are highly encouraged by the robust and durable clinical trial and registry data presented at this medical meeting,” added Daniel T. Lemaitre, President and CEO of CoreValve.  “Additionally, the 1000-patient milestone, confirms the presence of a significant patient population who can benefit from this groundbreaking technology.”

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.

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