NYSE:AORTMedical Equipment
Artivion (AORT) Is Up 10.1% After Full FDA PMA Approval for AMDS Aortic Device
In late June 2026, Artivion, Inc. received U.S. FDA premarket approval for its AMDS Hybrid Prosthesis to treat acute DeBakey Type I aortic dissections with malperfusion, removing prior Humanitarian Device Exemption constraints such as institutional review board approval.
This decision opens wider U.S. access to what Artivion sees as a US$150 million annual market and is backed by PERSEVERE trial data showing large reductions in early mortality and major complications versus standard...