Edwards Lifesciences Corporation has received approval from the US Food and Drug Administration (FDA) to treat high-risk aortic stenosis patients with the Edwards SAPIEN transcatheter aortic heart valve delivered both transfemorally (via the leg) and transapically (through the ribs). With the addition of high-risk patients to those eligible for the transcatheter procedure and with the approval of the transapical approach, a considerably broader group can now be treated with the SAPIEN valve. Previously, SAPIEN was approved in the US only for the treatment of inoperable patients via the transfemoral approach. The Edwards SAPIEN valve is indicated for the treatment of patients with severe symptomatic calcified native aortic valve stenosis who have been examined by a heart team, including an experienced cardiac surgeon and a cardiologist, and found to be inoperable or at high risk for traditional open heart surgery, and in whom existing comorbidities would not preclude the expected benefit from the procedure. The safety and effectiveness of the SAPIEN valve were evaluated in a randomised, controlled pivotal study called The PARTNER Trial. The trial was successful in meeting its primary endpoint at one year, concluding that survival of high-risk patients treated with the SAPIEN valve was equivalent to those treated with traditional open-heart surgery.