FDA Expands Indication for Edwards Sapien Valve to High-Risk Patients

October 19, 2012—Edwards Lifesciences Corporation (Irvine, CA) announced that it 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 and transapically.

In its press release, Edwards noted that the Sapien device was previously approved by the FDA for the treatment of inoperable patients via the transfemoral approach. Now, with the addition of high-risk patients to those already eligible for the transcatheter procedure and with the approval of the transapical approach, a considerably broader group can be treated with the Sapien valve in the United States.

According to Edwards Lifesciences, 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 open heart surgery, and in whom existing comorbidities would not preclude the expected benefit from the procedure. The previous FDA approval for the treatment of inoperable patients was granted on November 2, 2011, stated the company.

The safety and effectiveness of the Sapien valve were evaluated in PARTNER, a randomized, controlled pivotal trial. In April 2011, Edwards submitted a premarket application to the FDA based on data from PARTNER's high-risk cohort (cohort A), which compared the outcomes of patients at high risk for open heart surgery randomized to receive either surgical aortic valve replacement or the Sapien valve via transfemoral or transapical delivery. The trial was successful in meeting its primary endpoint at 1 year. The PARTNER investigators concluded that survival of high-risk patients treated with the Sapien valve was equivalent to those treated with traditional open-heart surgery.