Medtronic‘s Melody Transcatheter Pulmonary Valve just received the first FDA approval for use in patients whose previously implanted pulmonary valve has malfunctioned. Cardiac valves don’t last forever, and eventually degrade, requiring new open-heart surgeries. The new approval allows the Melody valve to be placed within the failed valve via a minimally invasive transcatheter procedure, thereby avoiding open-heart surgery, a major benefit for already fragile patients.
When delivering the Melody into an existing bioprosthetic valve, Medtronic’s recently unveiled Ensemble II Delivery System must be used because it is narrower and is easier to fit inside the valve conduits.
Some history about the Melody according to Medtronic:
The first transcatheter heart valve available anywhere in the world-and now implanted in more than 10,500 patients worldwide-the Melody TPV first received CE Mark in September 2006 for the treatment of failing pulmonary valve conduits. It was introduced in the U.S. in 2010 following FDA approval. Over the last 10 years, clinical evidence from three Medtronic clinical studies has demonstrated the valve’s effectiveness in delaying the need for open-heart reoperation.
Flashbacks: Medtronic Melody Transcatheter Pulmonary Valve Wins FDA PMA Approval…; Melody Transcatheter Artificial Valve Finally Gets Go Ahead in US…; Medtronic’s Transcatheter Pulmonary Heart Valve Used for Mitral Valve Replacement in Infants…; Melody Transcatheter Cardiac Valve Replacement Shows Good Results in Children…; Melody Transcatheter Pulmonary Valve Still Being Tested in the US…
Product page: Melody Transcatheter Pulmonary Valve…
Via: Medtronic…