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Inari Medical

HQ: Irvine, CA source · inarimedical.com ↗ · West Coast

FDA-cleared device company

Profile checked Oct 10, 2026

Keywords: Pulmonary Embolism Pulmonary Thromboembolism Venous Thromboembolism Deep Venous Thrombosis PE - Pulmonary Embolism PE - Pulmonary Thromboembolism Acute Lower Limb Arterial Occlusion Deep Vein Thrombosis In-stent Thrombosis Post-Thrombotic Syndrome Deep Vein Thrombosis Leg Chronic DVT of Lower Extremity Acute DVT of Lower Extremity Acute Pulmonary Embolism Submassive Pulmonary Embolism Massive Pulmonary Embolism FlowTriever System Percutaneous mechanical thrombectomy Artix Thrombectomy System ClotTriever® Thrombectomy System Thrombectomy Inari Medical Commercially Available Devices FlowTriever2 Catheter ClotTriever

14Trials (company is sponsor)7FDA records (2 yrs)

Timeline

  1. FDA FDA 510(k) clearance: Triever Duo Catheter — K253419, Sep 18, 2026. Applicant at approval: Inari Medical, Inc. source ↗
  2. FDA FDA 510(k) clearance: Artix™ MT;Artix™ Thin-Walled Sheath — K262538, Aug 21, 2026. Applicant at approval: Inari Medical, Inc. source ↗
  3. Trial start Not phased (device or behavioral study): The ArtixASCEND Study source ↗
  4. FDA FDA 510(k) clearance: Intri26 Introducer Sheath — K252508, Dec 17, 2025. Applicant at approval: Inari Medical, Inc. source ↗
  5. FDA FDA 510(k) clearance: Protrieve Sheath — K253323, Oct 29, 2025. Applicant at approval: Inari Medical. source ↗
  6. FDA FDA 510(k) clearance: InThrill™ Thrombectomy System — K250421, May 12, 2025. Applicant at approval: Inari Medical, Inc. source ↗
  7. FDA FDA 510(k) clearance: FlowTriever2 Catheter — K250088, Mar 13, 2025. Applicant at approval: Inari Medical, Inc. source ↗
  8. Trial start —: Inari VISION Registry source ↗
  9. Trial start Not phased (device or behavioral study): The Protrieve PROTECTOR Study source ↗
  10. Trial start —: ClotTriever® Thrombectomy System Use-Result Survey in Japan source ↗
  11. Trial start Not phased (device or behavioral study): The PERSEVERE Study source ↗
  12. FDA FDA 510(k) clearance: Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath — K241894, Oct 15, 2024. Applicant at approval: Inari Medical, Inc. source ↗
  13. Trial start —: RevCore for In Stent Thrombosis source ↗
  14. Trial start Not phased (device or behavioral study): The PEERLESS II Study source ↗
  15. Trial start Not phased (device or behavioral study): FlowTriever2 Pulmonary Embolectomy Clinical Study source ↗
  16. Trial start Not phased (device or behavioral study): DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis source ↗
  17. Trial start Not phased (device or behavioral study): The PEERLESS Study source ↗
  18. Trial start —: FlowTriever for Acute Massive Pulmonary Embolism (FLAME) source ↗
  19. Trial start —: FlowTriever All-Comer Registry for Patient Safety and Hemodynamics source ↗
  20. Trial start —: ClotTriever Outcomes (CLOUT) Registry source ↗
  21. Trial start Not phased (device or behavioral study): FlowTriever Pulmonary Embolectomy Clinical Study source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 14

RecordTitlePhaseStatusStartPrimary completion
NCT06588634The PERSEVERE StudyNot phased (device or behavioral study)RecruitingDec 16, 20242027-11 (estimated)
NCT06055920The PEERLESS II StudyNot phased (device or behavioral study)Active, not recruitingNov 17, 2023Jul 30, 2026 (actual)
NCT06495996The Protrieve PROTECTOR StudyNot phased (device or behavioral study)CompletedMar 5, 2025Nov 6, 2025 (actual)
NCT07135895The ArtixASCEND StudyNot phased (device or behavioral study)RecruitingJan 7, 2026Mar 1, 2029 (estimated)
NCT06871683ClotTriever® Thrombectomy System Use-Result Survey in JapanNot listedEnrolling by invitationFeb 17, 20252028-03 (estimated)
NCT06394739RevCore for In Stent ThrombosisNot listedRecruitingSep 9, 20242027-04 (estimated)
NCT05701917DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein ThrombosisNot phased (device or behavioral study)RecruitingJan 6, 2023Jan 31, 2028 (estimated)
NCT06600542Inari VISION RegistryNot listedRecruitingMar 7, 2025Dec 31, 2029 (estimated)
NCT05111613The PEERLESS StudyNot phased (device or behavioral study)CompletedFeb 14, 2022Mar 1, 2024 (actual)
NCT05560763FlowTriever2 Pulmonary Embolectomy Clinical StudyNot phased (device or behavioral study)CompletedFeb 14, 2023Sep 9, 2024 (actual)
NCT03761173FlowTriever All-Comer Registry for Patient Safety and HemodynamicsNot listedCompletedDec 15, 2018Sep 4, 2024 (actual)
NCT03575364ClotTriever Outcomes (CLOUT) RegistryNot listedCompletedSep 1, 2018Mar 25, 2022 (actual)
NCT04795167FlowTriever for Acute Massive Pulmonary Embolism (FLAME)Not listedCompletedMar 16, 2021Dec 19, 2022 (actual)
NCT02692586FlowTriever Pulmonary Embolectomy Clinical StudyNot phased (device or behavioral study)Completed2016-042017-11 (actual)

FDA records (last 2 years)

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