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FDA approves expanded indication for Sapien valve
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Edwards Lifesciences has announced that its Sapien transcatheter aortic heart valve has received FDA approval for the treatment of high-risk aortic stenosis through both the transfemoral and transapical approaches, broadening the population of patients that can now be treated with the device.
According to a press release issued by the manufacturer, the valve is now indicated for the treatment of patients with severe symptomatic calcified native aortic valve stenosis who have been examined by a heart team, including a cardiac surgeon and a cardiologist, and found to be inoperable or at high risk for traditional surgery. Additionally, patients must also not have existing co-morbidities that would preclude the expected benefit from the procedure.
This news follows the previous FDA approval of the valve for the treatment of inoperable patients via the transfemoral approach on Nov. 2, 2011.