Artivion’s AMDS Secures FDA PMA Approval, Opens $150M U.S. Market
AORT•FDA granted PMA approval for Artivion’s AMDS Hybrid Prosthesis to treat acute DeBakey Type I dissections covering ~60% of cases, eliminating hospitals’ IRB requirement and enabling broader U.S. adoption. PERSEVERE trial showed a 72% reduction in 30-day mortality, 54% drop in major adverse events and zero DANE tears.
1. PMA Approval Details
The FDA granted premarket approval for the AMDS Hybrid Prosthesis to treat acute DeBakey Type I aortic dissections with clinical or radiographic malperfusion, which account for approximately 60% of cases. This approval removes the institutional review board requirement previously associated with the HDE pathway, allowing immediate and broader device use across U.S. hospitals.
2. PERSEVERE Trial Results
Data from the PERSEVERE U.S. IDE trial showed a 72% reduction in all-cause mortality and a 54% decrease in primary major adverse events at 30 days, with zero distal anastomotic new entry tears compared to standard hemiarch repair. Two-year follow-up confirmed durable safety and efficacy, with stable aortic dimensions, continued true lumen expansion, and no additional aortic reoperations.
3. Market Opportunity
Each year approximately 6,000 U.S. patients present with acute DeBakey Type I dissections, representing an estimated $150 million annual market opportunity. The PMA approval positions Artivion to fully capitalize on this market following its HDE commercial launch.
4. Commercial and Strategic Impact
Artivion has built commercial and clinical infrastructure during the HDE launch, driving strong reordering momentum for AMDS. The recent acquisition of the PMA-approved NEXUS system and ongoing ARCEVO LSA trial enrollment further expand Artivion’s portfolio of aortic arch solutions.
