FDA panel to review Edwards SAPIEN valve next month

Edwards Lifesciences has announced that an FDA advisory panel is scheduled to review the company's PMA application for its Edwards SAPIEN transcatheter heart valve on July 20. Edwards submitted the application last fall based on data from the inoperable cohort (Cohort B) of The PARTNER Trial, for approval of this therapy in the treatment of inoperable patients with severe aortic stenosis.
Edwards Lifesciences release