Medtronic‘s Melody transcatheter pulmonary heart valve finally received FDA’s Pre-Market Approval (PMA) having had a Humanitarian Device Exemption (HDE) in the U.S. for the last five years. The Melody was the world’s first transcatheter heart valve and has been used in thousands of cases when open heart surgery would be too invasive, including more than 50% of those on children. The latest approval is based on three clinical studies that have shown that using the valve helps delay the need for open-heart procedures.
The Melody is indicated for patients with a dysfunctional right ventricular outflow tract (RVOT) conduit due to congenital heart disease, and is intended to drastically increase the time between surgeries.
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.
CHD is the most common birth defect in the United States; it affects an estimated 40,000 U.S. babies each year.1,2,3Approximately 20 percent of those infants have deformities that disrupt the blood flow from their RVOT to the pulmonary arteries.4 A subset of these children will receive a connecting conduit early in life to improve that blood flow. If a patient’s RVOT conduit fails later in life but is still of adequate size to address the patient’s needs (i.e., the patient has not outgrown the conduit), then a Melody TPV may be implanted to help delay a surgical pulmonic valve replacement, which is a much more invasive procedure than transcatheter valve replacement.
Flashbacks: Medtronic’s Transcatheter Pulmonary Heart Valve Used for Mitral Valve Replacement in Infants…; Melody Transcatheter Artificial Valve Finally Gets Go Ahead in US…; Medtronic’s Melody Transcatheter Pulmonary Valve on Track for Approval…; Melody™ Transcatheter Pulmonary Valve Still Being Tested in the US…; Melody Transcatheter Cardiac Valve Replacement Shows Good Results in Children…; The Melody™ Valve Approved in Canada…; The Melody™ Transcatheter Pulmonary Valve…
Product page: The Melody System…
Press release: FDA Grants Pre-Market Approval for Medtronic Melody® Transcatheter Pulmonary Valve…