FDA Approves Expanded Indication for Edwards Lifesciences' Transcatheter Valve
(Oct 19, 2012) - Edwards Lifesciences Corporation announced today that it has received approval from the United States 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. 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 U.S. only for the treatment of inoperable patients via the transfemoral approach.
"We are thankful to the multidisciplinary Heart Teams who worked diligently throughout The PARTNER Trial to bring new treatments to U.S. patients at high risk for surgical aortic valve replacement," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "It is extremely rewarding for us and our clinical partners to know that high-risk patients suffering from this often debilitating disease will now have access to this life-saving therapy."
About Transcatheter Aortic Valve Replacement (TAVR)
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 co-morbidities would not preclude the expected benefit from the procedure. The previous FDA approval for the treatment of inoperable patients was granted on Nov. 2, 2011.
The safety and effectiveness of the Sapien valve were evaluated in a randomized, controlled pivotal study called The PARTNER Trial. Edwards submitted a Premarket Application (PMA) 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 or the Sapien valve via transfemoral or transapical delivery. 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.