FDA okays Medtronic device to treat congenital heart disease

Melody Transcatheter Pulmonary Valve system

FRIDLEY, Minnesota — Medtronic Inc. said Monday the U.S. Food and Drug Administration has approved a new type of arterial valve designed mostly for young children suffering from congenital heart disease.

The company said its Melody system, the first transcatheter valve technology to receive approval in the United States, will help patients born with damage to their pulmonary valve, a type of spigot that 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 statement released by Medtronic. “The Melody valve gives patients with congenital heart disease a new, nonsurgical approach to managing their disease.”

Congenital heart defects (CHD) is the most common birth defect in America and the top killer of infants with birth defects, according to the American Heart Association, citing data from the federal 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 amounts to $2.6 billion a year, according to federal research.

Normally, doctors would have to crack open the chest to repair or replace the valve, a series of invasive and risky surgeries. The Melody system allows doctors to deliver a new valve through a catheter snaked up 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 FDA 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 (PMA) rules.