Acolyte Catheter System
IND- Indications
- Chronic total occlusion
Company intelligence / Profile preview
Simpson Interventions
Campbell, California, United Statessimpsonint.com ↗
- Ownership
- Private
- Employees
- ~12
- Development stage
- Commercial
01
Overview
Simpson Interventions has developed the Acolyte™ Image Guided Crossing and Re-entry Catheter System, which received FDA Breakthrough Device Designation in March 2024. The system enables precise guidewire placement using real-time optical coherence tomography during procedures to treat coronary chronic total occlusions. The company also achieved Investigational Device Exemption from the FDA to begin clinical studies of Acolyte™, while its Shadow Catheter™, designed for guidewire exchange/access in coronary/peripheral arteries, received FDA 510(k) clearance. Early-stage clinical results are pending as pivotal trials are ongoing or planned.
- Therapeutic areas
- Cardiovascular
- Modalities
- Device (specifically image-guided catheter systems)Non-pharmacological therapy (minimally invasive cardiovascular intervention)
- Industry
- Surgical Medical Devices
02
Drug pipeline
2 assets1 more asset in the full pipeline.
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Partnerships
BioPacific Investors (angel investment group with Asia connection)
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