http://www.theheart.org/article/1461227.do
FDA expands Sapien TAVI indication to high-risk surgical patients
Silver Spring, MD - The US Food and Drug Administration (FDA) has agreed to expand the approved use of the Sapien transcatheter aortic valve (Edwards Lifesciences) to high-risk aortic-stenosis patients who are also eligible for surgery, but at high risk of serious complications or death [1].
The decision follows a positive opinion in June 2012 from the agency's 12-member circulatory system devices panel, which voted unanimously that the device is effective, 10 to 2 that the device is safe, and 11 to 0 (with one abstention) that the device benefits outweighed any risks. The extended indication is based on the PARTNER A trial results, as reported by heartwire. In that study, one-year mortality was similar between the surgery and TAVR groups at 26.8% and 24.2%, respectively, meeting the predefined margin for noninferiority for transcatheter aortic-valve replacement (TAVR).
The approval includes TAVR via the transfemoral route—already approved for use in nonsurgical patients—as well as a newer transapical delivery system that can be used in patients whose femoral arteries are not suited to being the delivery route for the valve.
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More at link
FDA expands Sapien TAVI indication to high-risk surgical patients
Silver Spring, MD - The US Food and Drug Administration (FDA) has agreed to expand the approved use of the Sapien transcatheter aortic valve (Edwards Lifesciences) to high-risk aortic-stenosis patients who are also eligible for surgery, but at high risk of serious complications or death [1].
The decision follows a positive opinion in June 2012 from the agency's 12-member circulatory system devices panel, which voted unanimously that the device is effective, 10 to 2 that the device is safe, and 11 to 0 (with one abstention) that the device benefits outweighed any risks. The extended indication is based on the PARTNER A trial results, as reported by heartwire. In that study, one-year mortality was similar between the surgery and TAVR groups at 26.8% and 24.2%, respectively, meeting the predefined margin for noninferiority for transcatheter aortic-valve replacement (TAVR).
The approval includes TAVR via the transfemoral route—already approved for use in nonsurgical patients—as well as a newer transapical delivery system that can be used in patients whose femoral arteries are not suited to being the delivery route for the valve.
"
More at link
