Inova is proud to offer Melody®, the first FDA-approved transcatheter heart valve.
Melody® transcatheter pulmonary valve therapy is a non-surgical option for the lifetime management of congenital heart disease. It offers children and adults with failing pulmonary valve conduits a new option for treating pulmonary valve conduit failure without open heart surgery.
With Melody TPV therapy, a catheter (a thin, hollow tube) holding a specially designed heart valve is inserted into a vein in the leg and guided to the heart. The heart valve is attached to a stent (wire frame) that expands with help of a balloon to push the blocked pulmonary conduit open.
See the patient information website from the manufacturer
Humanitarian Device: Authorized by Federal law (USA) for use in pediatric and adult patients with a regurgitant or stenotic right ventricular outflow tract (RVOT) conduit (≥ 16 mm in diameter when originally implanted). The effectiveness of this device for this use has not been demonstrated.