Dublin, Ireland-based Medtronic has received U.S. 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), one of the four chambers of the heart, 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 typical congenital heart disease patient will face a multitude of open-heart surgeries over their lifetime, to continually address issues with their pulmonary valve. Furthermore, congenital heart disease patients require lifelong monitoring, preventive care and specialized treatment all the way from childhood to adulthood,” says Matthew J. Gillespie, MD, attending interventional cardiologist, co-director of the Pediatric Valve Center and director of the Cardiac Catheterization Laboratory at Children’s Hospital of Philadelphia, and principal investigator in the Harmony TPV Clinical Study.

Some of these patients may become candidates for the Medtronic Melody TPV later in life, the first transcatheter heart valve shown to effectively delay open-heart surgery. For the 80% of congenital heart disease patients who require a native or surgically repaired right ventricular outflow tract at birth, many will need a pulmonary valve replacement later in life, which historically has required another open-heart surgery. 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 availability of the Harmony TPV will allow a broader range of congenital heart disease patients access to transcatheter technology,” says Nina Goodheart, president of the structural heart and aortic business, which is part of the cardiovascular portfolio at Medtronic. “Harmony TPV’s novel attributes make it the only non-surgical solution designed to adapt to a wide variety of anatomies for this specific patient population living with congenital heart disease.”

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.