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# FDA Approves Medtronic Melody Transcatheter Pulmonary Valve
- URL: https://www.fdaweb.com/fda-approves-medtronic-melody-transcatheter-pulmonary-valve/
- Published: 2017-03-14T12:00:00.000Z
- Updated: 2026-09-14T22:11:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138190

FDA has approved a Medtronic PMA for its Melody Transcatheter Pulmonary Valve (TPV) and its implanted use in patients whose surgical bioprosthetic pulmonary heart valves have failed. The device is designed specifically for the pulmonic position. “Intended to prolong the time between open-heart surgeries for patients with a dysfunctional right ventricular outflow tract (RVOT) conduit caused by \[congestive heart disease\], the Melody TPV may now provide these patients with a minimally invasive treatment option,” the company says. It is placed inside a failing pulmonic surgical heart valve through the recently launched Ensemble II Delivery System, a low-profile, delivery catheter, specifically designed to deliver the valve.