FDA Approves Medtronic’s Melody Transcatheter Pulmonary Valve
Medtronic has achieved FDA approval for its Melody transcatheter pulmonary valve (TPV) for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed.
As surgical valves degenerates over time, patients may require another valve replacement, which would involve undergoing another open-heart surgery.
The device is intended to prolong the time between open-heart surgeries for patients with a dysfunctional right ventricular outflow tract conduit caused by CHD. Use of the Melody TPV allows for a minimally invasive treatment option.
During the procedure, the device is placed inside a failing pulmonic surgical heart valve through catheter specifically designed to deliver the Melody TPV.
The device received a CE Mark in September 2006 for the treatment of failing pulmonary valve conduits. It was introduced in the U.S. in 2010. — Cynthia Jessup