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.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in