Cardiac Research

The use of the Melody Transcatheter Pulmonary Valve (Melody TPV) for treatment of Right Ventricular Outflow Tract conduit Dysfunction in Accordance with the Melody Humanitarian Device Exemption Indications for Use

Priti M. Patel, MD

Some people with narrowing or absence of the valve between the right pumping chamber of the heart (ventricle) and the artery to the lungs (pulmonary artery) need surgery to treat the problem. Sometimes this includes placement of a tube called a “homograft” or “conduit” between the right ventricle and the pulmonary artery. Deterioration of this tube can result in narrowing and/or leakiness. Until now, the usual treatment has been another operation to replace the tube or a catheterization procedure to enlarge the area with a balloon catheter with or without placement of a wire mesh tube called a “stent”. The catheterization procedures treat narrowing but may increase leakiness. Most people with the tube connections between the right ventricle and pulmonary artery require several operations to replace them throughout their life.

The Medtronic Melody® Transcatheter Pulmonary Valve is a new type of valve that is supported by a stent and was developed to treat narrowing and leakiness in homograft and conduit tubes between the right ventricle and pulmonary artery. It is an approved humanitarian use device (HUD) for treatment of narrowing and/or leakiness in people with a homograft or circumferential conduit between the right ventricle and pulmonary arteries that was at least 16mm in diameter when placed. The approval of an HUD device means that the device is approved as safe and probably beneficial for specific indications because no comparable device is available to treat the disease or condition.