The FDA's advisory panel has proposed a review of Edward Lifesciences' premarket approval (PMA) application for its Edwards Sapien transcatheter heart valve on June 13. Edwards submitted a PMA application in April 2011 based on data from the high-risk cohort (Cohort A) of the PARTNER Trial, for approval of this therapy in the treatment of patients with severe, symptomatic aortic stenosis who are at high risk for surgery.
The high-risk cohort compared outcomes after treatment of 699 patients with either surgical valve replacement or the Edwards Sapien valve via transfemoral or transapical delivery. The one-year results of this study were presented in April 2011 at the American College of Cardiology's (ACC) annual scientific session by lead author Craig R. Smith, MD, and published in the New England Journal of Medicine in June 2011.
In addition to being linked to a 20 percent survival benefit at one-year, transcatheter aortic valve replacement (TAVR) patients also saw significant improvements in symptoms and quality of life. Patients who underwent TAVR procedures also saw a reduction in hospitalizations for aortic stenosis at one year, 22 percent vs. 44 percent.
The Edwards Sapien transcatheter heart valve received FDA approval for the treatment of certain inoperable patients in November 2011. It is currently an investigational device for the treatment of high-risk patients in the U.S. and is awaiting approval.