CoreValve System Approved for Severe Aortic Stenosis

Medtronic announced that the FDA has approved the CoreValve System, a self-expanding transcatheter for patients with severe aortic stenosis who are too ill or frail to have their aortic valves replaced through open-heart surgery.

Its self-expanding nitinol frame enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.

The FDA approval is based on clinical outcomes in the Extreme Risk Study, which demonstrated that the CoreValve System is safe and effective with high rates of survival and low rates of stroke and valve leakage. The 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<0.0001) in patients treated with the CoreValve than was expected. At one month, the rate of stroke was 2.4%, and it remained low with one-year rate of 4.1%.

The CoreValve System also achieved significant post-implant hemodynamics with results similar to surgical valves.

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