Medtronic (NYSE:MDT) said today it won extended FDA approval for its Melody transcatheter pulmonary valve, now indicated for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed.
The Fridley, Minn.-based company touted the Melody TPV as the 1st transcatehter pulmonary valve to win such an indication from the federal watchdog.
“Unlike other transcatheter valves currently on the market, Melody TPV is uniquely designed for use in the pulmonic position and is thus well suited for implantation in failed surgical pulmonary heart valves. This approval further demonstrates our commitment to improving treatment options for congenital heart disease and we look forward to bringing this proven non-surgical option to congenital patients,” heart valve therapies biz GM Rhonda Robb said in a prepared statement.
Medtronic said the Melody TPV is designed to replace surgical valves which have degenerated overtime without having to undergo a second open-heart surgery. The device is designed to be placed inside a failing pulmonic surgical heart valve with the Ensemble II delivery catheter system.
“As the 1st commercially available transcatheter heart valve, the Melody TPV brought a breakthrough non-surgical option to treat failing pulmonary valve conduits. Thousands of congenital patients globally have benefited from this therapy in the past decade. With this expanded indication, we can further reduce the need for obtrusive open-heart surgery and allow even more patients to benefit from this minimally invasive treatment option,” Dr. Jeremy Asnes of the Yale School of Medicine said in a press release.