SANTA ROSA – Santa Rosa-based Medtronic CardioVascular received unanimous approval today from an FDA panel to grant "Humanitarian Use Device" status to its Melody Transcatheter Pulmonary Valve, a decision that will expedite FDA approval of the device.
The first of its kind to be approved for commercial use, the valve addresses a relatively small population of patients with congenital heart defects - usually diagnosed in the womb or at birth. Because replacement valves wear out after a few years, those who have the defect traditionally need invasive surgery on a regular basis.
The transcatheter valve is sent to the heart from a small incision in the leg.
"Children have had to have open heart surgery several times before they're 18, at great risk from both the defect and the operation," said Dr. John Liddicoat, vice president and general manager of Medtronic's Cardiac Surgery Business who oversaw the valve's development. "We hope the Melody transcatheter valve will significantly reduce those operations."
Testifying during the panel's deliberations was Dan Matthys, a 37-year-old father of two and a patient at Duke University Medical Center who had received six open heart surgeries before receiving a Melody Valve a year and a half ago in a clinical trial.
"The effect on my life has been immeasurable," he said. "I was always fearful of my next surgery. Physically and psychologically the relief is tremendous. I can't thank the development team enough," he said.
About 1,000 of the Melody valves have been distributed worldwide since receiving approval in Europe and Canada in 2006.
Medtronic CardioVascular will work closely with the FDA on some final improvements and labeling issues, and training physicians in its use before it is approved for the U.S. market.
"We were very gratified to have such an overwhelmingly positive conclusion from the FDA panel today," said Dr. Liddicoat.