FDA Panel Backs Medtronic Heart Valve
WASHINGTON (AP) — Federal health advisers on Wednesday unanimously backed an experimental heart valve from Medtronic as a safe and effective treatment for patients with a rare heart defect.
The Food and Drug Administration's panel of heart experts voted 12 to 0 in favor of approving the Melody Pulmonary Valve, according to a company spokesman. The endorsement was made on the condition that Medtronic conducts a follow-up study of the device's safety.
The FDA is not required to follow the advice of its panels, though it normally does.
Medtronic, the world's largest medical device maker, has asked the FDA to approve the device for adults and children with a heart defect that disrupts blood flow between the hearts right chambers and the lungs. The valve is designed to be implanted using a small catheter, eliminating the need for open heart surgery
"The Melody valve attempts to decrease the total surgical burden on a patient," said Dr. John Liddicoat, a vice president with Medtronic.
About 1,000 patients in the U.S. could benefit from the device, according to Medtronic.