NYC-area 1st: Morgan Stanley Children's Hospital performs transcatheter pulmonary valve r...( The TPV device is currently only ava...),Health

The TPV device is currently only available in the research context to patients whose implanted valved-conduit has shown signs of narrowing and/or severe leakage. It is estimated that between 500 and 1,000 patients in the U.S. meet this criteria in a given year.

To date, 32 patients have been successfully implanted in the U.S., including 11 at Morgan Stanley Children's Hospital. In addition, nearly 300 patients have been successfully implanted with the device in Europe and Canada, where it has been approved for widespread use.

The initial feasibility study is sponsored by Medtronic, Inc. CardioVascular Business Unit of Minneapolis, Minn., makers of the Melody Transcatheter Pulmonary Valve (TPV) and Ensemble Transcatheter Delivery System used in the procedure. The study will look at the effectiveness of the procedure using echocardiography, chest radiography, fluoroscopy, cardiac MRI and other measures.

According to the American Heart Association (AHA), more than 25,000 U.S. babies are born each year with a congenital heart defect. Approximately 22 percent, or 4,800, of these babies born with congenital heart disease have defects disrupting the blood flow from the right ventricle to the pulmonary artery. For patients with this condition, their heart over-exerts itself trying to get oxygenated blood throughout the body. Additionally, they are at risk for arrhythmias and sudden death.

As part of a comprehensive interventional cardiology program, Morgan Stanley Children's Hospital offers a complete range of treatments for congenital heart conditions including atrial septal defects (ASD), ventricular septal defects (VSD), aortic stenosis (AS), patent ductus arteriosus (PDA), pulmonary atresia (PA) and more.