FDA approves Harmony Transcatheter Pulmonary Valve for congenital heart disease.- Medtronic

Medtronic announced it has received 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 FDA approval is based on clinical data from the Harmony TPV clinical study that showed excellent safety (freedom from mortality) and effectiveness (acceptable haemodynamic 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 Harmonization 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 pediatric devices as the development of medical devices for pediatric 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.