Edwards Lifesciences Corp.’s Sapien, used to replace a damaged aortic valve, will be covered by the U.S. government’s Medicare program.
The Centers for Medicare & Medicaid Services said today it would pay for the surgery to insert the Edwards valve that uses a catheter to allow doctors to avoid cracking open the chest, provided at least two cardiac surgeons evaluate the patient and determine the procedure is appropriate. The transcatheter aortic valve replacement should be done only by a team of doctors, including a heart surgeon and an interventional cardiologist, who perform the procedure at least 20 times a year, the agency said in a statement.
Medicare, the medical program for the elderly and disabled, also will pay for Sapien in patients who participate in clinical trials designed to see if the valve improves their health. The agency’s decision is expected to boost use of the device, which was approved in November by the Food and Drug Administration as the first less-invasive heart valve in the U.S. Sapien generated $41 million in U.S. sales in the first quarter for Irvine, California-based Edwards.
The final decision “will help clarify the reimbursement confusion that has existed since Sapien was launched in the U.S. last November, which should help accelerate Sapien sales,” said Larry Biegelsen, an analyst at Wells Fargo Securities in New York, in a note to investors today before the decision was released.
Medtronic Inc., based in Minneapolis, is developing a transcatheter aortic valve that is in the final trials needed for U.S. marketing approval.