CoreValve is an option for patients who can’t have open-heart surgery.
Medtronic Inc.’s CoreValve replaced damaged aortic valves more safely than expected in patients who can’t tolerate traditional open-heart surgery, leading U.S. regulators to say it won’t need an advisory committee review.
The Food and Drug Administration found the study presented Tuesday in San Francisco provided enough information to determine if the valve should be sold in the United States, Fridley-based Medtronic said. The company now expects it will get U.S. approval for extreme-risk patients by April.
The study, the first of the CoreValve in the U.S., found 25.5 percent of patients died or suffered a stroke within a year compared with the predicted 43 percent. Medtronic’s device will compete with Edwards LifeSciences Corp.’s Sapien, the only rival available in the U.S. market.
“This was truly a patient population who wouldn’t be suitable for surgical aortic valve replacement,” said Jeffrey Popma, director of interventional cardiology at the Beth Israel Deaconess Medical Center in Boston. “The positive clinical outcomes and low complication rates set a high standard for what transcatheter valves can achieve.”
Medtronic shares rose 1.5 percent to close at $58.50, their highest price since January 2006. Edwards, based in Irvine, Calif., fell 4.6 percent to $69.86.
The valve improved quality of life and eased heart failure symptoms, according to the study presented at the Transcatheter Cardiovascular Therapeutics conference. The device is already sold in Europe. Twenty-two percent of patients needed a pacemaker after the procedure.
There are about 300,000 people worldwide with severe aortic stenosis, a narrowing of the valve between the left ventricle and the aorta. Blood can back up in the heart, leading to chest pain, breathlessness and weakness. One in three patients can’t tolerate the open-heart surgery that has been proven to improve quality and lengthen life.