CoreValve (www.corevalve.com) 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. More than 1,800 patients have now been treated worldwide at nearly 100 centers in 20 countries.
IRVINE, Calif. (Business Wire EON) October 13, 2008 -- During the Monday Transcatheter Aortic Valve Replacement sessions at TCT 2008 meeting in Washington, D.C., CoreValve investigators and physician proctors presented clinical data on the subset of patients that are included in the company's post CE-Mark expanded clinical evaluation registry. Patients enrolled in the registry had a predicted 30-day mortality rate of about 23% as measured by the logistical EuroScore. By contrast, the survival rate at one-month post-procedure follow-up for these high-risk and often inoperable octogenarian registry patients was about 90%. Quality of life improvement, as measured by the New York Heart Association (NYHA) functional classification, was significantly improved as well. Follow-up on patients that are now one year post procedure demonstrate good longer term valve function and sustained survival and quality of life benefits. CoreValve believes that complications including neurological events are comparable to traditional aortic valve surgery although there is a modest, but clinically acceptable increase in pacemaker dependency in PAVR patients.
"The growing volume of very positive clinical data from an ever increasing number of physicians is most satisfying," said Eberhard Grube MD, Chief of Cardiology at the HELIOS Heart Center Siegburg, Germany. "In the hands of an experienced user, use of the CoreValve ReValving System is fast becoming a routine alternative for high risk patients suffering from severe aortic stenosis."
"We are highly encouraged by the clinical data from outside the United States that was presented at TCT," added Daniel T. Lemaitre, President and CEO of CoreValve. "Additionally, we continue to see strong sequential growth in procedure volume as 2008 unfolds; a testimony to the significant patient population whom we believe will benefit from our groundbreaking technology."
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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