{"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","discovered_at":"2026-05-14T18:03:11.015851+00:00","generated_at":"2026-05-29T05:57:33.901198+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"FDA grants Artivion HDE for AMDS Hybrid Prosthesis in acute DeBakey Type I dissections with malperfusion","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0000784199-24-000254","json":"https://secwatch.observer/filing/0000784199-24-000254.json","markdown":"https://secwatch.observer/filing/0000784199-24-000254.md","text":"https://secwatch.observer/filing/0000784199-24-000254.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T05:57:33.901198+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}