

Medtronic proudly announced that the FDA, thanks to outstanding study results, has bypassed asking an independent advisory panel for comment and approved the CoreValve transcatheter valve replacement system for patients with severe aortic stenosis who are not eligible for open heart surgery. The Extreme Risk Study, which looked at incidences of stroke and survival rates, clearly beat the endpoints developed with the help of the FDA, and essentially there were no critical points to debate that would normally require a review panel.

The CoreValve is available in sizes ranging from 23mm to 31mm, and all are delivered via an 18 French (6mm) catheter, the narrowest currently available for any transcatheter valve prosthesis.

Some details from the announcement:

The Extreme Risk Study met its primary endpoint of death or major stroke at one year with a rate of 25.5 percent, which was 40.7 percent lower (p<0.0001) in patients treated with the CoreValve than was expected (based on a performance goal developed in partnership with the FDA). At one month, the rate of stroke was 2.4 percent, and it remained low over time with a one-year rate of 4.1 percent. Additionally, 75.6 percent of patients were alive at one-year. Contemporary results through the Continued Access Study, an extension of the U.S. pivotal Trial, demonstrated even better survival and stroke performance. In the U.S. Pivotal Trial, the CoreValve System also achieved exceptional hemodynamics, or blood flow, post-implant with results similar to the gold standard, surgical valves. Additionally, valve leakage (known as paravalvular leak or PVL) rates were low and decreased over time as the self-expanding valve conformed to the shape of a patient’s annulus – an improvement that has not been reported in other major TAVR studies. The CoreValve System was developed to serve the needs of the broadest range of patients with severe aortic stenosis. The FDA approved the entire CoreValve platform including the CoreValve Evolut™ 23mm, and the CoreValve 26mm, 29mm and 31mm valves.

Flashbacks: Previous Medgadget coverage of CoreValve…

Press release: Medtronic CoreValve® System Obtains Early FDA Approval on Exceptional Clinical Performance…