Artivion IncAORT
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FDA premarket approval for its AMDS Hybrid Prosthesis, enabling full market access.
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Artivion IncArtivion has received U.S. FDA premarket approval for its AMDS Hybrid Prosthesis, the world's first aortic arch remodeling device for treating acute DeBakey Type I aortic dissections. The approval was supported by the PERSEVERE U.S. IDE trial, which demonstrated a 72% reduction in all-cause mortality and a 54% reduction in primary major adverse events at 30 days compared to the standard hemiarch procedure, with zero distal anastomotic new entry tears. AMDS was previously available under a Humanitarian Device Exemption. The company stated that the PMA approval positions it to fully address an estimated $150 million annual U.S. market opportunity. Artivion shares rose more than 2% in pre-market trading after closing at $23.61 on Friday.
Artivion IncFDA premarket approval for its AMDS Hybrid Prosthesis, enabling full market access.