On Jan. 27, the FDA approved a transcatheter artificial heart valve for sale in the U.S. This applies to both Medtronic's Melody Transcatheter Pulmonary Valve and its delivery catheter, the Ensemble Transcatheter Valve Delivery System.
The artificial heart valve, an organic cow vein valve sewn onto a small metal frame, is delivered by catheter to the failing heart valve. It is intended for patients with heart defects that require multiple surgeries throughout their lifetime and should delay additional open heart surgery.
The system was discussed at the 2014 American College of Cardiology scientific session in Washington, D.C. There, researchers announced that 99 patients had a procedural success rate of 98 percent at more than 24 hours and freedom from valve dysfunction was 97 percent at one year, with primary endpoints on effectiveness met and exceeded.
“It supports what we found in the trial done more than five years ago,” Aimee K. Armstrong, MD, of the University of Michigan C.S. Mott Children’s Hospital Cardiac Catheterization Laboratories told Cardiovascular Business at the time.
Currently, the FDA states that there are no known contraindications for the Melody valve.