Artivion receives FDA PMA approval for AMDS Hybrid Prosthesis

• Artivion (NYSE:AORT) received U.S. FDA premarket approval for its AMDS Hybrid Prosthesis to treat acute DeBakey Type I aortic dissections with malperfusion.
• The approval removes HDE-related institutional review board requirements and is backed by PERSEVERE trial data.
• Artivion estimates the annual U.S. market opportunity for this indication at approximately $150 million.

Artivion (NYSE:AORT) announced that the U.S. Food and Drug Administration has granted premarket approval for its AMDS Hybrid Prosthesis for the treatment of acute DeBakey Type I aortic dissections with malperfusion.

This indication represents about 60% of acute DeBakey Type I aortic dissections.

The PMA approval removes HDE-related institutional review board requirements for the device.

The approval is supported by data from the PERSEVERE trial, which demonstrated positive clinical outcomes in patients with this life-threatening condition.

Artivion estimates the annual U.S. market opportunity for this indication at approximately $150 million.

The AMDS Hybrid Prosthesis is designed to treat the aortic arch and false lumen while preserving native vessels and allowing for future interventions.