March 29, 2021 – Medtronic plc (Dublin, Ireland) announced it has received U.S. Food and Drug Administration (FDA) approval for its Harmony Transcatheter Pulmonary Valve (TPV), the first minimally invasive therapy created to treat patients with a specific type of congenital heart defect of the right ventricle (RV), which makes it difficult for blood to travel from the heart to the lungs.
The Harmony TPV, which is placed inside a patient’s native anatomy during a catheter-based procedure, was designated as a Breakthrough Therapy under FDA’s Breakthrough Device Designation (BDD) program, an approval pathway intended to help patients receive more timely access to certain life-saving technologies.
The Harmony TPV provides these patients with an alternative to the more invasive open-heart surgical approach; instead, the valve is loaded onto a catheter and delivered via a small incision in the femoral vein or in the neck and placed directly inside the heart.
The Harmony TPV device is available for use in the United States. Outside of the U.S., Harmony TPV is limited to investigational use and not approved for sale or distribution.