FDA Approves First Nonsurgical Heart Valve for Congenital Heart Disease Patients

The FDA has approved Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) system, the world’s first nonsurgical heart valve for the right-ventricular outflow tract (RVOT).

The device is designed to treat pediatric and adult patients with severe pulmonary valve regurgitation, which involves blood leaking backward into the heart’s lower right chamber. It serves as a less-invasive alternative to open-heart surgery.

The device is implanted through a vein in the groin or neck into the right side of the heart and then into the RVOT, using a thin, hollow catheter with a collapsed Harmony valve on the end. After it is released from the catheter, the valve self-expands and anchors to the RVOT.