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 or non-operable for conventional open-heart valve replacement surgery.
Edwards Lifesciences received approval from the U.S. Food and Drug Administration (FDA) to begin a pivotal clinical trial of its Edwards SAPIEN Transcatheter heart valve technology. The PARTNER (Placement of AoRTic traNscatheterER valves) trial will evaluate the Edwards SAPIEN valve in patients with calcific aortic stenosis who are considered high-risk for conventional open-heart valve surgery.
The PARTNER trial is designed for patients with severe calcific aortic stenosis who might not be optimal candidates 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 open-heart surgery.
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