Medtronic’s Transcatheter Harmony Valve For Congenital Pulmonary Defect Wins FDA Approval

The Harmony transcatheter pulmonary valve can be used to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation as a result of a congenital malformation of the right ventricular outflow tract.

A pair of adult-sized hands surround the hands of a child, which themselves hold a red toy heart with an EEG line design on it. — • Source: Shutterstock

A newly approved minimally invasive treatment for congenital heart defects could help up to 8,000 newborns per year, the US Food and Drug Administration announced on 26 March.

The agency approved a PMA for Medtronic’s Harmony transcatheter pulmonary valve (TPV) system in pediatric and adult patients . Harmony...