Shots:
- Simpson Interventions reported the grant of IDE by the US FDA to Acolyte Image-Guided Crossing & Re-Entry Catheter System plus 510(k) clearance for its Shadow Catheter
- Acolyte System intends to enables cardiologists with revascularization of coronary chronic total occlusion (CTO). In Mar 2024, it was designated with the US FDA’s BDD and included into the Total Product Life Cycle Advisory Program Pilot (TAP Pilot)
- The single-use/disposable Shadow Catheter is intended to use in combination with steerable guidewires to access distinct areas of coronary and peripheral arterial vasculature, enabling dual guidewire use, device exchange, and delivery of diagnostic or therapeutic agents
Ref: BusinessWire | Image: Simpson
Related Newswire:- Simpson’s Acolyte Image Guided Crossing and Re-Entry Catheter System Gains the US FDA’s Breakthrough Device Designation
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