Medtronic Wins Nod for a ‘World’s First’ Implant
Dublin-based Medtronic won approval for a non-surgical heart valve to treat pediatric and adult patients with a congenital heart disease in late March. The Harmony Transcatheter Pulmonary Valve System offers a less invasive option to treat patients with a native or surgically-repaired right ventricular outflow tract the part of the heart that carries blood out of the right ventricle to the lungs. The device is designed for patients who have severe pulmonary valve regurgitation (blood leaking backward into the right lower chamber of the heart), a condition that often results from congenital heart disease.
The device was called a first and was one of the first groundbreaking approval for a cardiovascular device in 2021. It could have the potential to open the door for other such devices.