Medtronic's Melody TPV Receives FDA Premarket Approval

February 3, 2015—Medtronic announced that its Melody transcatheter pulmonary valve (TPV) received premarket approval (PMA) from the US Food and Drug Administration (FDA).

According to Medtronic, the FDA approval is supported by the evidence demonstrating the valve’s effectiveness in delaying open-heart reoperation for patients with a dysfunctional right ventricular outflow tract conduit caused by congenital heart disease (CHD). In 2010, the Melody TPV was approved under an FDA humanitarian device exemption.

The PMA approval is based on accumulated data from the three clinical studies that followed a total of 310 patients implanted with Melody TPV:  the Melody US investigational device exemption study, the Melody US Postapproval Study (PAS), and the Melody European and Canadian Postmarket Surveillance Study.

Data showed strong valve performance in all three studies in patients implanted with the Melody valve. Approximately 98% of patients were free from conduit reoperation at 1 year after implantation. Additionally, 91% of patients in the IDE cohort were free from conduit reoperation at 5 years after implantation, reported the company.

William E. Hellenbrand, MD, commented in Medtronic’s announcement, “The Melody valve has been a reliable option for patients suffering from CHD, and these data reinforce its strong performance since it was first introduced. This approval underscores the valve’s importance in treating this small patient population, who over their lifetime will face several open-heart surgeries.” Dr. Hellenbrand is Chief of Pediatric Cardiology at the Yale School of Medicine in New Haven, Connecticut.