http://www.theheart.org/article/130...tm_medium=email&utm_source=20111102_breaking2
Silver Spring, MD - The US Food and Drug Administration has approved the first-ever transcatheter valve for the treatment of inoperable aortic-stenosis disease, the Sapien (Edwards Lifesciences) [1].
The FDA's decision comes within months of a positive opinion from its Circulatory System Devices Committee, which, back in July, voted 7 to 3 that the device demonstrated reasonable assurances of safety, 9 to 1 that the device demonstrated reasonable assurances of efficacy, and 9 to 0 (with one abstention) that its benefits outweighed the risks.
The valve device is approved for "patients who are not eligible for open-heart surgery for replacement of their aortic valve and have a calcified aortic annulus," an FDA press release notes. "The product label advises that a heart surgeon should be involved in determining if the Sapien [transcatheter valve] is an appropriate treatment for the patient
more at link
Silver Spring, MD - The US Food and Drug Administration has approved the first-ever transcatheter valve for the treatment of inoperable aortic-stenosis disease, the Sapien (Edwards Lifesciences) [1].
The FDA's decision comes within months of a positive opinion from its Circulatory System Devices Committee, which, back in July, voted 7 to 3 that the device demonstrated reasonable assurances of safety, 9 to 1 that the device demonstrated reasonable assurances of efficacy, and 9 to 0 (with one abstention) that its benefits outweighed the risks.
The valve device is approved for "patients who are not eligible for open-heart surgery for replacement of their aortic valve and have a calcified aortic annulus," an FDA press release notes. "The product label advises that a heart surgeon should be involved in determining if the Sapien [transcatheter valve] is an appropriate treatment for the patient
more at link
