The U.S. Food and Drug Administration said that it has approved Medtronic Inc.'s (MDT) Melody Transcatheter Pulmonary Valve and Ensemble Delivery System.
The company claims that this is the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery, the company added.
Conduits are surgically implanted valves used to treat congenital heart defects of the pulmonary valve. They can have a limited lifespan and often require replacement. The Melody is intended to provide another option to conduit replacement.
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