COMPANY
Reflow Medical
FDA-cleared device company Clinical Phase 1
Timeline
- FDA FDA 510(k) clearance: Kiba CTO Crossing Catheter — K262013, Aug 28, 2026. Applicant at approval: Reflow Medical, Inc. source ↗
- Trial start Not phased (device or behavioral study): Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia source ↗
- FDA FDA 510(k) clearance: CoraForce Microcatheter, CoraFlex Microcatheter — K251277, Aug 22, 2025. Applicant at approval: Reflow Medical, Inc. source ↗
- FDA FDA De Novo grant: Spur Peripheral Retrievable Stent System — DEN240048, May 29, 2025. Applicant at approval: Reflow Medical, Inc. source ↗
- Trial start Phase 1: Pilot Study of the Coronary Spur Stent for In-stent Restenosis (DEEPER CORONARY) source ↗
- Trial start Phase 3: Single-Arm Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions source ↗
- Trial start Not phased (device or behavioral study): A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL) source ↗
- Trial start Not phased (device or behavioral study): A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB source ↗
- Trial start Not phased (device or behavioral study): A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee source ↗
- Trial start Not phased (device or behavioral study): ReFlow Medical Wingman Catheter Wing-IT Clinical Trial source ↗
- Trial start Not phased (device or behavioral study): Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy. source ↗
Upcoming milestones
- 2032-06 (ESTIMATED) · Not phased · Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia · NCT06122974
Clinical trials (lead sponsor) 8
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT03807531 | A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee | Not phased (device or behavioral study) | Active, not recruiting | Jul 11, 2019 | Apr 30, 2023 (actual) |
| NCT06117150 | Pilot Study of the Coronary Spur Stent for In-stent Restenosis (DEEPER CORONARY) | Phase 1 | Completed | Jun 12, 2024 | Jul 29, 2025 (actual) |
| NCT05358353 | A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL) | Not phased (device or behavioral study) | Completed | Oct 18, 2022 | May 15, 2024 (actual) |
| NCT06122974 | Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia | Not phased (device or behavioral study) | Not yet recruiting | 2026-08 | 2032-06 (estimated) |
| NCT05848232 | Single-Arm Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions | Phase 3 | Unknown status (ClinicalTrials.gov) | 2024-06 | 2025-01 (estimated) |
| NCT04162418 | A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB | Not phased (device or behavioral study) | Completed | Feb 14, 2020 | Jun 30, 2022 (actual) |
| NCT03403426 | ReFlow Medical Wingman Catheter Wing-IT Clinical Trial | Not phased (device or behavioral study) | Completed | Feb 13, 2018 | Aug 8, 2019 (actual) |
| NCT03669458 | Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy. | Not phased (device or behavioral study) | Completed | Oct 6, 2017 | Jun 4, 2019 (actual) |
FDA records (last 2 years)
- FDA 510(k) clearance: Kiba CTO Crossing Catheter — K262013, Aug 28, 2026. Applicant at approval: Reflow Medical, Inc. source ↗
- FDA 510(k) clearance: CoraForce Microcatheter, CoraFlex Microcatheter — K251277, Aug 22, 2025. Applicant at approval: Reflow Medical, Inc. source ↗
- FDA De Novo grant: Spur Peripheral Retrievable Stent System — DEN240048, May 29, 2025. Applicant at approval: Reflow Medical, Inc. source ↗
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