Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Harmony Transcatheter Pulmonary Valve (TPV), a 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 year and about 1.6 million adults currently living with congenital heart disease.
"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 specialised treatment all the way from childhood to adulthood," said Matthew J. Gillespie, attending interventional cardiologist, co-director of the Paediatric Valve Centre and director of the Cardiac Catheterisation 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 lungs, 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.
Nina Goodheart, president of the structural heart & aortic business at Medtronic, said: "The availability of the Harmony TPV will allow a broader range of congenital heart disease patients access to transcatheter technology. 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 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 Harmony TPV qualified as a proof-of-concept product for the Harmonisation by Doing (HBD) for Children program. The HBD for Children program was established as a partnership among stakeholders of academia, industry and regulatory agencies in Japan and the United States, with a primary focus on the development of paediatric devices as the development of medical devices for paediatric use lags behind that of medical devices for adults in both countries. 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.
