Artivion Announces U.S. FDA Approval of the AMDS Hybrid Prosthesis
Artivion received FDA PMA approval for its AMDS Hybrid Prosthesis to treat acute Debakey Type I aortic dissections, eliminating the need for institutional review board approval. The approval is supported by data from the PERSEVERE trial, which demonstrated a 72% reduction in all-cause mortality and zero occurrence of DANE tears at 30 days compared to standard care. This regulatory milestone allows Artivion to fully penetrate an estimated $150 million annual U.S.
Key figures
- Drug Name
- AMDS Hybrid Prosthesis
- Mae reduction
- 54%
- Market opportunity
- $150 million
- Trial participants
- 93
- Mortality reduction
- 72%
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