Transcatheter aortic valve replacement patients who are unable to undergo surgery: CoreValve System has obtained early FDA approval


The FDA ( Food and Drug Administration ) has approved of the self-expanding transcatheter CoreValve System for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. Untreated, these patients have a risk of dying approaching 50% at one year.

The FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve U.S. Pivotal Trial, which demonstrated that the CoreValve System is safe and effective with high rates of survival and some of the lowest rates of stroke and valve leakage reported.

The Extreme Risk Study met its primary endpoint of death or major stroke at one year with a rate of 25.5%, which was 40.7% lower ( p less than 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%, and it remained low over time with a one-year rate of 4.1%.
Additionally, 75.6% 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 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.
With the broadest size range available, the CoreValve System is suitable for patients with native valves of nearly all sizes.
Its self-expanding Nitinol frame enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.
All valve sizes are delivered via the smallest ( 18Fr, or 6mm ) TAVR delivery system available, making it possible to treat patients with difficult or small vasculature. ( Xagena )

Source: Medtronic, 2014

XagenaMedicine_2014



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