DUBLIN, March 26, 2021 /PRNewswire/ -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today 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), 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.
Congenital heart disease (CHD) is the most common type of birth defect in the United States, affecting an estimated 40,000 infants each year1 and 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, M.D., 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.
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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.