FDA approves Sapien for high-risk TAVR patients

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Edwards Lifesciences chalked up another victory for its Sapien transcatheter aortic heart valve with the FDA’s approval to use the valve in high-risk aortic stenosis patients. The valve may be delivered both transfemorally and transapically.

“Any procedure to replace the aortic valve carries the risk for serious complications, but for some patients with coexisting conditions or diseases that risk may be especially high,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health, in a release. “The THV [transcatheter heart valve] serves as an alternative for some very high-risk patients.”

The Sapien valve previously won FDA approval for the treatment of inoperable patients on Nov. 2, 2011. But it was approved only for the treatment of inoperable patients via the transfemoral approach, according to Edwards Lifesciences. The company said the FDA’s current decision broadens the pool of potential candidates for transcatheter aortic valve replacement (TAVR).

The 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 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 heart team must include an experienced cardiac surgeon and a cardiologist.

The device is contraindicated for patients who cannot tolerate anticoagulation/antiplatelet therapy.

On June 13, the FDA’s Circulatory Systems Devices Panel recommended approval for the Sapien heart valve system for the indication to treat patients with severe, systematic aortic stenosis who are at high risk for surgery. Panel members voted 10-2 that the Sapien valve was overall safe in high-risk aortic stenosis patients.

The safety and effectiveness of the Sapien valve were evaluated in the randomized, controlled pivotal PARTNER Trial. Edwards submitted its Premarket Application in April 2011 based on data from the high-risk cohort (Cohort A) of the PARTNER Trial. Cohort A compared the outcomes of patients at high risk for traditional open-heart surgery randomized to receive either surgical aortic valve replacement (AVR) or the Sapien valve via transfemoral or transapical delivery.

FDA noted that both groups had similar death rates at one month, one year and two years after the procedures. “Those who received the THV showed an increased risk for major vascular complications, such as artery dissection or perforation, and for stroke during the first month following the procedure,” according to FDA. “Patients who received the AVR were more likely than the THV recipients to experience major vascular bleeding during the procedure.”

Irvine, Calif.-based Edwards Lifesciences will continue to evaluate the device through a national registry.