WASHINGTON -- Federal health officials say they have 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 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.
Congenital heart defects are the most common birth defects worldwide, according to the FDA.
Medtronic is the world's largest device maker.
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