USA – FDA okays first-in-world valve to address congenital heart disease

The US Food and Drug Administration (FDA) announced Friday that it approved a first-in-world device to address pulmonary valve regurgitation in patients with some kinds of congenital heart disease, along with a device meant to help gait problems in people with multiple sclerosis.

The Harmony Transcatheter Pulmonary Valve (TPV) system is a less invasive option than open-heart repair for severe pulmonary valve regurgitation in patients with a native or surgically repaired right ventricular outflow tract (RVOT).

“The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of congenital heart disease. It offers a less-invasive treatment alternative to open-heart surgery to patients with a leaky native or surgically-repaired RVOT and may help patients improve their quality of life and return to their normal activities more quickly, thus fulfilling an unmet clinical need of many patients with congenital heart disease,” said Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in FDA’s Center for Devices and Radiological Health (CDRH)…