Results from the most recent feasibility studies on the Melody transcatheter valve, Medtronic's expected blockbuster cardiovascular device, are in, and so far, it still sounds good.

On Monday at the American Heart Association's Scientific Session in Orlando, Fla., doctors shared the results of six month to one year follow ups of 99 patients who received the Melody valve in U.S. trials.

Melody, currently available in Europe, is an investigational device that's designed to replace congenitally defective pulmonary valves, the part of the heart that brings blood in contact with oxygen from the lungs. Unlike most replacement surgeries, which are open-chest operations, Melody is threaded up the body in a minimally invasive catheter procedure.

"Our main finding: in the period of time since study began we have continued to see good short-term function of the conduit, and we've been able to implant these devices at a very low level of risk," Thomas Jones, M.D., an investigator of the device and the director of the cardiac catheterization labs at Seattle Children's Hospital, University of Washington, tells DOTmed News. "Both safety and efficacy have continued to far exceed the bar that was set in the original clinical study that was posed to the FDA."

The valve appeared to hold up well in the study, conducted at five leading children's hospitals in the U.S., including Boston's Children's Hospital and the Morgan Stanley Children's Hospital in New York. After one year, virtually all patients - 99 percent - didn't require full-blown surgical intervention, and only 13 percent of the stents showed any fractures. Of those who had stent fractures, only six needed reintervention to correct stenosis, which was mainly done in a second catheter procedure, often by simply inserting another transcatheter valve in place of the damaged one.

But the procedure wasn't for everybody. Around four patients had to drop out because of the danger of coronary artery compression. Due to differences in heart anatomy, a small number of patients are at risk of having the valve affect coronary artery bloodflow, and are thus not eligible for it.

No compressions were seen in the study, though, and Dr. Jones credits that to the protocol they're developing that will help doctors avoid implanting Melody in someone who would be at risk for compression. "We're confident that the way we're assessing it is going to minimize that risk," he says. "It's one of the important steps in the pre-implant evaluation...and it's an important reason why a minority of patients may not be able to be treated with the new device."

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