FDAnews Device Daily Bulletin

Edwards Lifesciences to Study Expanded Indication of Heart Valve

Jan. 19, 2016

Edwards Lifesciences scored a victory at the FDA with approval for an expanded indication study of its Edwards SAPIEN 3 aortic heart valve.

The study will enroll elderly patients with severe, symptomatic aortic stenosis who are deemed to be at low risk for mortality if they were to undergo surgical aortic valve replacement.

It will enroll roughly 1,300 patients at up to 50 sites, with plans to begin during the second quarter. 

The valve was approved by the FDA last year for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis. — Michael Cipriano