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Catheter-Delivered Valve May Help People With Heart Defects Avoid Multiple Surgeries
Date:10/26/2009

Multicenter study in 30 children and young adults shows good early outcomes

BOSTON, Oct. 26 /PRNewswire-USNewswire/ -- Children born with certain heart defects have impaired blood flow from the right ventricle to the pulmonary artery leading to the lungs, requiring implanted devices (known as right-ventricular outflow tract conduits) to maintain the flow. However, these conduits fail over time, and children typically face multiple open-heart operations during their lives to reopen the passage. Now, a prospective multicenter study in the October 27 issue of the Journal of the American College of Cardiology, led by Children's Hospital Boston cardiologist Doff McElhinney, MD, finds good preliminary outcomes with a valve that can be delivered non-surgically -- threaded up a leg vein to the heart -- potentially avoiding the need for repeated open-heart operations.

(Photo: http://www.newscom.com/cgi-bin/prnh/20091026/DC98727)

The device, known as the Melody transcatheter pulmonary valve (Medtronic, Inc), received backing from an FDA advisory panel in July, suggesting FDA approval may come soon for certain patients. (See http://www.reuters.com/article/healthNews/idUSTRE56L71020090722). The device is currently approved in Europe and Canada; if approved by the FDA, it could be the first catheter-placed heart valve to be approved in the U.S.

"With a transcatheter valve, you don't have to open the chest and put the patient on heart-lung bypass machine, with all that that entails," says McElhinney. "Patients can come in, have a catheter procedure, stay overnight, then go home the next day."

The study, the first prospective, multicenter study of the device, involved 34 children and young adults at Children's Hospital Boston, Miami Children's Hosp
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SOURCE Children's Hospital Boston
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