In November of 2011, the U.S. Food and Drug Administration (FDA) approved the Edwards SAPIEN Transcatheter Heart Valve for the treatment of patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement, and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis. The Edwards SAPIEN Valve is the first transcatheter aortic valve replacement (TAVR) therapy approved for use in the U.S., and select hospitals are now performing the procedure on qualified patients.
This transcatheter procedure enables the placement of a collapsible aortic heart valve into the body via the catheter-based RetroFlex 3 transfemoral delivery system, which allows the Edwards SAPIEN valve to be inserted via the femoral artery in the groin. The valve is designed to replace a patient’s diseased native aortic valve without traditional open-heart surgery and while the heart continues to beat – therby the need for cardiopulm bypass is not required.
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