Medtronic Heart Valve Approved for Broader Use
Medtronic Inc. said Thursday that the FDA approved its artificial heart valve, CoreValve, for use in more patients who face serious risks from open-heart surgery, the standard treatment.
Medtronic's implant is a less invasive approach to replacing diseased aortic heart valves, which can often lead to heart failure, blood clots and sudden death.
The Food and Drug Administration first approved the implant in January, but only for patients who are so sick or frail that surgery is not an option. The additional FDA approval allows Medtronic to market its device to a much broader group of patients who are healthier but would still face serious risks from surgery.
Every year about 50,000 people in the U.S. undergo open-heart surgery for aortic valve replacement, which involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place.
CoreValve and a similar device from Edwards Lifesciences are delivered through a catheter that is snaked up to the heart through an incision in the groin.
The FDA approved the expanded use of CoreValve based on data showing that one year after the procedure 86 percent of patients were still alive, compared with 81 percent of patients undergoing traditional surgery.
The FDA approved Edwards' Sapien valve for the broader group of patients in October 2012.
Last month Medtronic agreed to pay Irvine, California-based Edwards $1 billion to settle a long-standing patent dispute over the technology used in their artificial valves.