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Artivion

HQ: Kennesaw, GA source · artivion.com ↗ · Southeast

FDA-cleared device company Clinical Phase 3

Location: Kennesaw, GA · source · Oct 15, 2026

Profile checked Oct 10, 2026

Keywords: Acute Aortic Dissection Aortic Arch Aneurysm Aortic Arch Dissection Chronic Aortic Dissection Mitral Regurgitation Vascular Diseases Peripheral Arterial Disease Carotid Artery Diseases Abdominal Aortic Aneurism Aortic Valve Disease Aortic Valve Stenosis Aortic Valve Failure Congenital Heart Disease Cardiac Anomaly Surgical Blood Loss PhotoFix Chord-X system implant

7Trials (company is sponsor)2FDA records (2 yrs)

Timeline

  1. FDA FDA PMA approval: AMDS Hybrid Prosthesis — P250055, Jun 26, 2026. Applicant at approval: Artivion, Inc. source ↗
  2. Trial start —: Mitral Valve Repair With the Chord-X System: A Long Term Evaluation source ↗
  3. Trial start Not phased (device or behavioral study): Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA source ↗
  4. FDA FDA 510(k) clearance: CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) — K252059, Oct 2, 2025. Applicant at approval: Artivion, Inc. source ↗
  5. Trial start Not phased (device or behavioral study): PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection source ↗
  6. Trial start —: Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery source ↗
  7. Trial start Phase 3: PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban source ↗
  8. Trial start Not phased (device or behavioral study): Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery source ↗
  9. Trial start Not phased (device or behavioral study): Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 7

RecordTitlePhaseStatusStartPrimary completion
NCT07089576Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSANot phased (device or behavioral study)RecruitingNov 4, 20252028-04 (estimated)
NCT07413926Mitral Valve Repair With the Chord-X System: A Long Term EvaluationNot listedNot yet recruiting2026-062034-03 (estimated)
NCT05174767PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I DissectionNot phased (device or behavioral study)Active, not recruitingMay 27, 2022Dec 11, 2023 (actual)
NCT03669042Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular SurgeryNot phased (device or behavioral study)CompletedNov 20, 2018Jul 10, 2020 (actual)
NCT04142658PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on ApixabanPhase 3TerminatedMay 1, 2020Dec 12, 2022 (actual)
NCT05314868Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction SurgeryNot listedTerminatedMar 31, 2022Nov 30, 2022 (actual)
NCT02359994Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic SystemNot phased (device or behavioral study)Completed2015-04Jan 11, 2019 (actual)

FDA records (last 2 years)

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