FDA expands approval of the Melody transcatheter pulmonary valve

The FDA approved the Melody transcatheter pulmonary valve for patients whose surgical bioprosthetic pulmonary heart valves failed.

Medtronic, the valve’s manufacturer, announced the approval in a news release on March 14.

The company said the Melody was the first FDA-approved transcatheter pulmonary valve for this indication.

If surgical valves deteriorate, patients may have to undergo another open-heart surgery, according to Medtronic. With the Melody, those patients might now have an alternative, minimally invasive treatment option.

The FDA originally approved the Melody in 2010. It was previously approved in Europe and was the first transcatheter heart valve available in the world. Since then, more than 10,500 patients have been implanted with the Melody.

Medtronic said clinicians insert the Melody in a failing pulmonic surgical heart valve through the recently launched Ensemble II delivery system.

“As the first commercially available transcatheter heart valve, the Melody TPV brought a breakthrough non-surgical option to treat failing pulmonary valve conduits,” Jeremy Asnes, MD, associate professor of pediatric cardiology and director of the Congenital Cardiac Catheterization Laboratory at the Yale School of Medicine, said in a news release. “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.”