FDA grants Artivion HDE for AMDS Hybrid Prosthesis in acute DeBakey Type I dissections with malperfusion

ARTIVION, INC.

HDE covers ~40% of US acute DeBakey Type I dissections; PMA expected late 2025 for full $150M annual market.
PERSEVERE trial: 72% reduction in all-cause mortality, 54% reduction in major adverse events vs. standard hemiarch at 30 days.
AMDS is world's first aortic arch remodeling device; previously granted Breakthrough and HUD designations.
Company to begin IRB approvals, VAC submissions, and surgeon training to prepare for commercial launch.
Enterprise shareholders to receive 0.60 Independent shares + $2.00 cash per share; total consideration ~$562M.

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