The FDA is making Medtronic very proud by awarding the company the first US regulatory approval for a transcatheter cardiac valve replacement. The Melody system is designed to be an alternative option to open heart surgery, and it will now be indicated for peds and adults with congenital heart disease who have dysfunctional right ventricular outflow tract conduits. The Melody Transcatheter Pulmonary Valve and Ensemble Delivery System have received European approval back in 2006. We’ve been covering this system for the last four years and we are honestly happy to see it’s finally making the debut to the cardiac market.
From a statement by the FDA:
Clinical studies of 99 participants in the United States and 68 participants in Europe showed that the device improved function of the heart, and the majority of participants have noted improvements in their clinical symptoms. The device showed similar, limited durability compared with existing alternative treatments; 21 percent of U.S. participants experienced a stent fracture, a rate consistent with stent fractures reported for the bare metal stents presently used to treat congenital heart defects of the pulmonary valve.
As a condition of the FDA’s approval, the system’s manufacturer, Medtronic Inc. of Minneapolis, will conduct two post-approval studies to assess long-term risks and benefits as well as to evaluate the physician specialization needed to perform the implantation procedure, also called generalizability. One study will continue to follow 150 participants from the initial clinical trial for five years, and the second study will enroll more than 100 new participants to be evaluated over five years, in order to evaluate and assess the training program. Safety and benefit assessments will be part of both studies. The FDA also requires that Medtronic maintain a database of Melody recipients.
Here’s a video of an implanted Melody valve in action:
Press releases: FDA Approves First Percutaneous Heart Valve…; Medtronic Receives FDA Approval for First Replacement Heart Valve Implanted Without Surgery…
Flashbacks: Melody Transcatheter Cardiac Valve Replacement Shows Good Results in Children; Medtronic’s Melody Transcatheter Pulmonary Valve on Track for Approval; Melody Transcatheter Pulmonary Valve Still Being Tested in the US; The Melody Transcatheter Pulmonary Valve