Reporter: Aviva Lev-Ari, PhD, RN
The Edwards SAPIEN transcatheter heart valve is an investigational device which is placed either through a transfemoral ( RetroFlex 3 Transfemoral Delivery System) or transapical ( Ascendra Transapical Delivery System) approach. The Edwards SAPIEN valve is being evaluated in the treatment of patients with severe calcific aortic stenosis who are considered to be high-risk for conventional open-heart valve replacement surgery.Cohort A of the PARTNER (Placement of AoRTic traNscatheterER valves) Trial is designed for patients with severe calcific aortic stenosis who are considered to be high-risk for conventional open-chest valve replacement due to the risk surgery might pose to them. These patients may be eligible to participate in a new, investigational transcatheter valve replacement procedure that is performed without
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