Investigational Devices


	Investigational Devices

Edwards SAPIEN Transcatheter Heart Valve

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
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CAUTION: Investigational device. Limited by Federal law to investigational use. This product has not been approved for marketing in the United States, and is not available for commercial sale in the United States.