October 14, 2008 - CoreValve said 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.
At TCT 2008, 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 ~23 percent 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 percent. 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 CoreValve ReValving System will not be available in the U.S. for clinical trials or for sale until further notice.
For more information: www.corevalve.com