The U.S. Food and Drug Administration (FDA) on March 26 approved the Harmony Transcatheter Pulmonary Valve as the world's first nonsurgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract. The device is designed for patients who have severe pulmonary valve regurgitation and is intended to both delay and reduce the number of required lifetime open-heart surgeries by improving blood flow to the lungs. Read more.