By Thomas Lee
FRIDLEY, Minnesota- The Food & Drug Administration approved a new type of arterial valve designed for patients, mostly young children, suffering from congenital heart disease made by Medtronic Inc. (NYSE:MDT).
The company said its Melody system, the first kind of transcatheter valve technology to receive approval in the United States, will help patients born with damage to their pulmonary valve, which manages blood flow between the heart and lungs.
“The Melody Transcatheter Pulmonary Valve is a significant technological breakthrough and offers a reprieve for many patients with congenital heart disease — many of whom are young and will require several heart surgeries over their lifetime,” Dr. William E. Hellenbrand, a pediatric cardiologist with NewYork‐Presbyterian Morgan Stanley Children’s Hospital and Columbia University Medical Center, said in a press release. “The Melody valve gives patients with congenital heart disease a new, non‐surgical approach to managing their disease.”
Congenital heart defects are the most common birth defect in America and the top killer of infants with birth defects, according to the American Heart Assn., citing data from the Centers for Disease Control. An estimated 36,000 babies, or one out of every 1,000, are born with CHD every year. Total hospital costs to treat CHD amount to $2.6 billion a year, according federal research.
Normally, doctors would have to crack open a patient’s chest to repair or replace the valve, in a series of invasive and risky surgeries. The Melody system allows doctors to deliver a new valve through a catheter snaked through blood vessels. Medtronic says it’s developing transcatheter technology for all four valves of the heart: Aortic, mitral, pulmonic and tricuspid.
Regulators in Europe and Canada have already approved Melody. A special panel of experts advising the FDA unanimously green-lighted the technology last July. The agency approved Melody under its Humanitarian Device Exemption program, which clears novel technologies to treat less than 4,000 patients a year without meeting efficacy requirements under normal pre-market approval rules.