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. CoreValve, in which the replacement valve is threaded into place through an artery using a catheter, spares patients chest-cracking surgery. 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.
U.S. FDA approves Medtronic heart valve replacement system.