Medtronic Revises Design of CoreValve Pivotal Trial

Medtronic, Inc. MDT today announced it has received conditional approval from the U.S. Food and Drug Administration to modify its CoreValve U.S. Pivotal Clinical Trial. In the revised design, the trial will assess the CoreValve System in extreme risk patients in a single arm study with a primary endpoint of all-cause death or major stroke within 12 months. Furthermore, the revision includes the evaluation of alternate implantation routes for delivering the transcatheter valve, such as the subclavian approach.