Simpson’s Acolyte Image Guided Crossing and Re-Entry Catheter System Gains the US FDA’s Breakthrough Device Designation

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The US FDA has granted breakthrough device designation to the company’s Acolyte Image Guided Crossing and Re-Entry Catheter System for treating coronary chronic total occlusions (CTOs)
The Acolyte system positions guidewires and catheters properly into the coronary vasculature to treat coronary CTOs patients whose symptoms persist post-medical therapy
The device further offers real-time optical coherence tomography (OCT) visualization & navigation capabilities for placing guidewires and catheters into the target vessel’s true lumen enabling CTO crossing to improve surgeries

Ref: Simpson | Image: Simpson

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