U.S. FDA Approves AMDS Hybrid Prosthesis for Acute DeBakey Type I Aortic Dissections

Artivion, Inc. announced that the U.S. FDA has approved the premarket approval application (PMA) for its AMDS Hybrid Prosthesis. This device is the world's first aortic arch remodeling device for treating acute DeBakey Type I aortic dissections, and its approval will reduce administrative burden on hospitals by removing the need for institutional review board (IRB) approval for implantation.