---
schema_version: "secwatch.filing_event.v1"
accession: "0000784199-24-000254"
form_type: "8-K"
ticker: "AORT"
cik: "0000784199"
company_name: "ARTIVION, INC."
filed_at: "2024-12-09T23:59:59+00:00"
generated_at: "2026-05-29T05:57:33.901198+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0000784199-24-000254
- form_type: 8-K
- ticker: AORT
- cik: 0000784199
- company_name: ARTIVION, INC.
- filed_at: 2024-12-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/784199/000078419924000254/0000784199-24-000254-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/784199/000078419924000254/aort-20241209.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000784199-24-000254
- JSON: https://secwatch.observer/filing/0000784199-24-000254.json
- Plain text: https://secwatch.observer/filing/0000784199-24-000254.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.