The US FDA has approved Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) System, the first in the world nonsurgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), according to the agency. The RVOT is the part of the heart that carries blood out of the right ventricle to the lungs.

The device is designed for patients who have severe pulmonary valve regurgitation (blood leaking backward into the right lower chamber of the heart), a condition that often results from congenital heart disease. The Harmony Transcatheter TPV System is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery, which is the current standard of care.

According to the FDA, use of the Harmony valve may delay the time before a patient needs additional open-heart surgery. It can also potentially reduce the total number of open-heart surgeries required over an individual’s lifetime, the agency said in a press release.

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.

Congenital heart disease (CHD) is the most common type of birth defect in the United States, affecting an estimated 40,000 infants each yearand about 1.6 million adults currently living with congenital heart disease2.

“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,” said 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.

Approximately one in five patients born with CHD have structural malformations that disrupt the connection between the heart and the lungs3, called the right ventricular outflow tract (RVOT). The standard of care today in the U.S. requires that these patients receive open-heart surgery or other interventions early in life to address these malformations. 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 CHD patients who require a native or surgically repaired RVOT 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.

According to Medtronic, the FDA approval is based on clinical data from the Harmony TPV clinical study that showed excellent safety (freedom from mortality) and effectiveness (acceptable hemodynamic function) at 30 days and six months, respectively. Data from the study also showed patients treated with Harmony TPV experienced no significant reinterventions, reoperations or endocarditis at six months.

“The availability of the Harmony TPV will allow a broader range of congenital heart disease patients access to transcatheter technology,” said Nina Goodheart, president of the Structural Heart & 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 US, Harmony TPV is limited to investigational use and not approved for sale or distribution.