FDAnews Device Daily Bulletin

Edwards’ Sapien transcatheter heart valve appears poised for broader use after an FDA panel voted in favor of approving a PMA that would expand the device’s indication to a select group of high-risk heart patients. The Circulatory System Devices Panel voted 10-2 Wednesday that the Sapien is safe for treating patients with a 15 percent or greater mortality risk in traditional aortic valve replacement, and unanimously agreed it is effective. The 12 panel members, with one abstaining, also said the device’s benefits outweighed its risks.
Devices & Diagnostics Letter