"The remarkable thing about this procedure is that the valve is placed into the beating heart through a vein in the patient's leg. After the procedure, patients spend a night on the hospital ward and are discharged home the following morning," said Laurie Armsby, M.D., associate professor of pediatric cardiology at OHSU Doernbecher and Burch's partner in the OHSU Pediatric and Adult Congenital Cardiac Catheterization Lab. "This device brings us closer to the goal of providing children less invasive alternatives to surgery for the treatment of congenital heart disease."
More than 1,700 patients have been implanted worldwide since the valve was approved for commercial use in Europe in 2006. According to the FDA, an estimated 1,000 U.S. children and adults with congenital heart disease will qualify for the new valve annually.
Drs. Burch and Armsby are the only pediatric cardiologists in Oregon with advanced training in interventional cardiology. Together they perform more than 300 cardiac catheterizations in newborns, children, and adults with congenital heart disease each year.
The FDA approved the Melody valve under the Humanitarian Device Exemption provision, which allows for the use of devices determined to be safe and whose benefits to health outweigh the risk of injury or illness. A Humanitarian Use Device (HUD) is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. The exemption is only given when there are no comparable devices available to treat or diagnose the disease or condition.
|Contact: Tamara Hargens-Bradley|
Oregon Health & Science University