WASHINGTON – Federal health officials on Monday approved a first-of-a-kind heart valve from Medtronic that can be implanted without open heart surgery.
The Food and Drug Administration cleared the company's Melody Pulmonary Valve for adults and children with a heart defect that disrupts blood flow between the heart's right chambers and lungs.
Patients with the condition currently receive replacement valves that can break down over time, requiring multiple heart surgeries to replace them. Medtronic's device is implanted using a small catheter that is inserted through an incision in the leg, postponing the need for surgery.
"The FDA's approval of Melody allows patients to undergo a much less invasive procedure to treat their condition," said FDA device chief Dr. Jeffrey Shuren, in a statement.
Regulators cleared the device under a program reserved for devices that treat rare diseases affecting fewer than 4,000 patients per year. Devices are approved based on safety and "probable benefit," though hard data showing effectiveness may not be available.
As part of FDA's approval decision, Medtronic agreed to conduct two studies of the long-term risks of the device and physician expertise needed to implant it.
The Melody valve was approved in Europe in 2006.
Minneapolis-based Medtronic Inc. is the world's largest device maker.
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