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Shockwave Medical

shockwavemedical.com ↗ · West Coast

Status: Acquired, now part of Johnson & Johnson · How status works

FDA-cleared device company Past trials only

Keywords: medical device Peripheral Arterial Disease Coronary Artery Disease Myocardial Infarction Refractory Angina Carotid Artery Calcification Carotid Artery Diseases Mitral Valve Regurgitation Coronary Arterial Disease Angina Pectoris Stable Angina Pectoris Chronic Stable Angina Peripheral Artery Disease Peripheral Vascular Disease Coronary Stenosis Vascular Disease Angioplasty Intravascular Lithotripsy Lithotripsy Shockwave Lithoplasty System Shockwave Medical Mini S Peripheral IVL Catheter Carotid Intravascular Lithotripsy (IVL) Carotid Intravascular Lithotripsy Reducer System Shockwave Medical Coronary IVL System Mitral valve replacement IVL with Shockwave C2+ 2Hz Coronary IVL Catheter Peripheral Intravascular Lithotripsy (IVL) TIARA valve and transapical delivery system Shockwave C2 Coronary IVL Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) IVL Coronary Lithotripsy System Shockwave Coronary Rx Lithoplasty® System Shockwave Lithoplasty® System Shockwave Coronary Lithoplasty System Shockwave System Treatment Neovasc Reducer Metricath Gemini System

Profile checked Oct 10, 2026

28Trials (company is sponsor)2FDA records (2 yrs)

Timeline

  1. FDA FDA 510(k) clearance: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter — K262201, Jul 27, 2026. Applicant at approval: Shockwave Medical, Inc. source ↗
  2. Trial start Not phased (device or behavioral study): Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE source ↗
  3. Trial start Not phased (device or behavioral study): Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE source ↗
  4. FDA FDA 510(k) clearance: Shockwave CS Guide Catheter — K243757, May 2, 2025. Applicant at approval: Shockwave Medical, Inc. source ↗
  5. Trial start Not phased (device or behavioral study): FORWARD CAD IDE Study source ↗
  6. Trial start Not phased (device or behavioral study): Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal Arteries source ↗
  7. Trial start Not phased (device or behavioral study): Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO) source ↗
  8. Trial start Not phased (device or behavioral study): FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter source ↗
  9. Trial start —: Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease source ↗
  10. Trial start Not phased (device or behavioral study): Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System source ↗
  11. Trial start Not phased (device or behavioral study): Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II source ↗
  12. Trial start Not phased (device or behavioral study): Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System source ↗
  13. Trial start —: Disrupt CAD III Post-Approval Study (PAS) source ↗
  14. Trial start Not phased (device or behavioral study): Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL System source ↗
  15. Trial start Not phased (device or behavioral study): Disrupt CAD IV With the Shockwave Coronary IVL System source ↗
  16. Trial start Not phased (device or behavioral study): Disrupt CAD III With the Shockwave Coronary IVL System source ↗
  17. Trial start Not phased (device or behavioral study): Shockwave Coronary Lithoplasty® Study (Disrupt CAD II) source ↗
  18. Trial start —: DISRUPT PAD III Observational Study source ↗
  19. Trial start Not phased (device or behavioral study): Tiara™ Transcatheter Mitral Valve Replacement Study source ↗
  20. Trial start Not phased (device or behavioral study): Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III) source ↗
  21. Trial start Not phased (device or behavioral study): Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis source ↗
  22. Trial start —: REDUCER-I: An Observational Study of the Neovasc Reducer™ System source ↗
  23. Trial start Not phased (device or behavioral study): Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I) source ↗
  24. Trial start Not phased (device or behavioral study): Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2) source ↗
  25. Trial start Not phased (device or behavioral study): Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System source ↗

Showing 25 of 30 dated events.

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 28

RecordTitlePhaseStatusStartPrimary completion
NCT05102019Efficacy of the COronary SInus Reducer in Patients With Refractory Angina IINot phased (device or behavioral study)RecruitingJan 4, 20222027-07 (estimated)
NCT06662500FORWARD CAD IDE StudyNot phased (device or behavioral study)RecruitingApr 4, 2025Dec 8, 2025 (actual)
NCT05058456Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL SystemNot phased (device or behavioral study)CompletedMar 16, 2022Dec 19, 2023 (actual)
NCT07062471Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study)Not phased (device or behavioral study)RecruitingJun 22, 20262027-10 (estimated)
NCT07512128Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)Not phased (device or behavioral study)Not yet recruiting2026-072027-12 (estimated)
NCT02710435REDUCER-I: An Observational Study of the Neovasc Reducer™ SystemNot listedActive, not recruiting2016-032023-11 (actual)
NCT05755711Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery DiseaseNot listedActive, not recruitingMay 3, 2023Dec 11, 2024 (actual)
NCT02276547Early Feasibility Study of the Neovasc Tiara™ Mitral Valve SystemNot phased (device or behavioral study)CompletedFeb 5, 2015Jan 6, 2020 (actual)
NCT05858905FORWARD PAD IDE Study With the Shockwave Javelin IVL CatheterNot phased (device or behavioral study)CompletedJun 27, 2023Apr 5, 2024 (actual)
NCT05007925Disrupt PAD BTK II Study With the Shockwave Peripheral IVL SystemNot phased (device or behavioral study)CompletedNov 18, 2021Mar 25, 2024 (actual)
NCT05966662Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)Not phased (device or behavioral study)CompletedDec 8, 2023Jan 9, 2025 (actual)
NCT06938854Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal ArteriesNot phased (device or behavioral study)Active, not recruitingMar 10, 2025Jan 31, 2027 (estimated)
NCT03039855Tiara™ Transcatheter Mitral Valve Replacement StudyNot phased (device or behavioral study)CompletedMar 8, 2017Dec 19, 2019 (actual)
NCT05021757Disrupt CAD III Post-Approval Study (PAS)Not listedCompletedMar 10, 2021Mar 31, 2022 (actual)
NCT04585763Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL SystemNot phased (device or behavioral study)CompletedFeb 16, 2021Aug 25, 2021 (actual)
NCT02923193Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)Not phased (device or behavioral study)CompletedFeb 22, 2017May 12, 2020 (actual)
NCT05881421DISRUPT PAD III Observational StudyNot listedCompletedNov 16, 2017Jun 10, 2021 (actual)
NCT04151628Disrupt CAD IV With the Shockwave Coronary IVL SystemNot phased (device or behavioral study)CompletedNov 6, 2019May 8, 2020 (actual)
NCT03595176Disrupt CAD III With the Shockwave Coronary IVL SystemNot phased (device or behavioral study)CompletedJan 9, 2019May 7, 2020 (actual)
NCT03328949Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)Not phased (device or behavioral study)CompletedMay 18, 2018Mar 26, 2019 (actual)
NCT02650128Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)Not phased (device or behavioral study)Completed2015-122016-09 (actual)
NCT02369848Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)Not phased (device or behavioral study)Completed2015-062015-12 (actual)
NCT02911623Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular StenosisNot phased (device or behavioral study)Completed2016-062017-05 (actual)
NCT02758379Shockwave Coronary Lithoplasty StudyNot phased (device or behavioral study)Completed2014-072016-01 (actual)
NCT02071108Safety and Performance Study of the Shockwave Lithoplasty SystemNot phased (device or behavioral study)Completed2014-012014-10 (actual)
NCT01577888Safety and Feasibility Study of the Shockwave Lithoplasty SystemNot phased (device or behavioral study)Completed2012-082014-08 (actual)
NCT01205893Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRAPhase 2Completed2010-092013-10 (actual)
NCT00399646Evaluation of the Metricath Gemini System, a Device Intended to Make Arterial Measurements and Perform Angioplasty Dilations.Phase 2Completed2005-112007-11 (actual)

FDA records (last 2 years)

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