"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 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.
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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.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
SOURCE Medtronic plc
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