FDA approves Melody TPV for Heart Surgery-Medtronic

Medtronic has announced that its Melody Transcatheter Pulmonary Valve (TPV) received Pre-Market Approval (PMA) from the FDA based on strong clinical evidence from three clinical studies demonstrating the valve's effectiveness in delaying open-heart reoperation. The first transcatheter heart valve available in the world, the Melody TPV was originally approved in 2010 under a Humanitarian Device Exemption (HDE), a regulatory approval for treatments intended for fewer than 4,000 U.S. patients per year. HDEs are granted for medical devices that have demonstrated reasonable safety and probable benefit, but do not have evidence of clinical effectiveness. PMA approval has been issued based on the robust evidence now available that supports both safety and effectiveness of the Melody TPV.

The PMA approval is based on accumulated data from three clinical studies that followed a total of 310 patients implanted with Melody TPV - the Melody U.S. IDE Study, the Melody U.S. Post Approval Study (PAS) and the Melody European and Canadian Post-Market Surveillance Study (PMSS). Data showed strong valve performance in all three studies in patients implanted with the Melody valve as approximately 98 percent of patients were free from conduit reoperation (open-heart surgery) at one year post-implant. Additionally, 91 percent of patients in the IDE cohort were free from conduit reoperation at five years post-implant.