Medtronic: Harmony transcatheter pulmonary valve
Medtronic won FDA approval for its Harmony transcatheter pulmonary valve system on March 26. The device is a non-surgical heart valve that treats severe pulmonary valve regurgitation.
The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease may need additional open-heart surgery, according to the company. It could also reduce the number of open-heart surgeries needed over time.
Medtronic’s device can be used in adult and pediatric patients who have certain types of congenital heart diseases. It is implanted using a thin catheter with a collapsed Harmony valve at the end. The catheter is inserted through a vein in the groin or next to it and run into the right side of the heart and then into the right ventricular outflow tract.