Latest Heart News
In a news release, the agency said the Medtronic Melody Transcatheter Plumonary Valve and Ensemble Delivery System could delay the need for open heart surgery to replace a previously implanted valve "conduit" that has stopped functioning properly.
A conduit is implanted to treat a leak or other defect, present at birth, of the heart's pulmonary valve, which helps regulate the system that carries blood from the heart's right ventricle to the lungs.
The Melody system doesn't "cure" the heart condition, and like a conduit, can wear out over time and require replacement, the FDA said. But the Melody can allow a conduit to continue functioning, delaying the need for open heart surgery. This can especially benefit a child born with the heart condition who would otherwise face additional surgeries during his or her lifetime.
The FDA said it is requiring Medtronic to conduct post-approval studies to assess the product's long-term risks and benefits.
-- Scott Roberts
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