FDA Clears Percutaneous Valve for RVOT Conduit

January 25, 2010

January 25, 2010 (Silver Spring, Maryland) — The US Food and Drug Administration (FDA) has approved a new transcatheter pulmonary valve (Melody, Medtronic) for use in patients with congenital disorders affecting the right ventricular outflow tract (RVOT) who have undergone prior surgery [1].

The agency approved the device under the humanitarian-device-exemption (HDE) program, which is a special type of approval for therapies used in fewer than 4000 people in the US each year. In July 2009, as previously reported by heartwire , the FDA's Circulatory System Devices Panel voted unanimously in its recommendation for approval.

The FDA said that the device is a new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits. Complications with RVOT conduits typically require surgical intervention, but the percutaneous valve implant allows patients to undergo a less invasive procedure to improve conduit function, delaying the need for further open-heart surgery.

The device has already been approved for use in Europe and Canada and has been used in more than 850 patients and more than 75 centers.


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