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FDA Approved Pulmonary Prosthetic Valve for Percutaneous Implantation

Henry I. Bussey, Pharm.D., FCCP, FAHA
March, 2010

The FDA recently announced approval of a prosthetic pulmonary valve, the Melody from Medtronics, that can be implanted without open heart surgery. The greatest value of this new device is likely to be for children with congenital disease who otherwise may have to undergo more than one open-heart surgical procedure. The use of the Melody valve will help manage such patients and delay a subsequent open-heart procedure. The FDA announcement, which outlines limitations on the use of the new valve and planned post-approval studies, is available online at www.fda.gov/NewsEvents/Newsroom/
PressAnnouncements/ucm198597.htm
and an image of the procedure is available at s.wsj.net/public/resources/images/OB-EU512_melody_G_20091102182547.jpg

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Saturday, October 12, 2024