Edwards Lifesciences Earns CE Mark for CENTERA Valve

Edwards Lifesciences received a CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery.

The valve is repositionable and retrievable and can be delivered through a motorized delivery system.

The CE Mark was based on the trial results from a study of 203 high-risk patients at 23 centers in Europe, Australia and New Zealand.