U.S. FDA approves Medtronic heart valve replacement system

By Reuters Staff

(Reuters) - Medtronic Inc's non-invasive system for replacing diseased heart valves won U.S. approval for use in patients deemed too frail to endure traditional open heart surgery, the U.S. medical device maker said on Friday.

The Food and Drug Administration approved Medtronic's CoreValve system based on U.S. clinical trials in which it was shown to be safe and effective while demonstrating low rates of stroke and valve leakage, the company said.

With CoreValve, the replacement valve is threaded into place through an artery using a catheter. The system has been available since 2007 in Europe, where it is not uncommon for medical devices to win approval several years ahead of the United States.

In the CoreValve Extreme Risk study, which was presented in October 2013 at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference in San Francisco, the device met its primary goals of reducing mortality and stroke in frail elderly patients with severe aortic stenosis who were considered too ill for surgery.

The rate of death or major stroke after one year was 25.5%, significantly below the study's goal of 43%, in the 471 patients treated with the valve. The patients' average age was 83 years.

"The fact that nearly three-quarters of patients were alive and free of strokes at one year is remarkable, given the complex medical conditions and extreme frailty of this population," Dr. Jeffrey Popma of Beth Israel Deaconess Medical Center in Boston, a co-principal investigator of the study, said at the conference.

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