Medtronic’s Harmony Transcatheter Pulmonary Valve Approved by FDA

March 26, 2021—Medtronic announced it has received FDA approval for its Harmony transcatheter pulmonary valve (TPV) to treat patients with a specific type of congenital heart defect, structural malformations that disrupt the right ventricular outflow tract. The Harmony TPV was designated as a Breakthrough Therapy under FDA’s Breakthrough Device designation program.

According to the company, 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 6 months, respectively. Data from the study also showed patients treated with Harmony TPV experienced no significant reinterventions, reoperations, or endocarditis at 6 months.

Matthew J. Gillespie, MD, who is attending Interventional Cardiologist, Codirector of the Pediatric Valve Center, and Director of the Cardiac Catheterization Laboratory at Children’s Hospital of Philadelphia in Philadelphia, Pennsylvania, served as an investigator in the Harmony TPV clinical study.

“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,” commented Dr. Gillespie in Medtronic’s announcement. “Furthermore, congenital heart disease patients require lifelong monitoring, preventive care, and specialized treatment all the way from childhood to adulthood.”