Simpson Interventions Receives FDA Breakthrough Device Designation for Acolyte™ System

Simpson Interventions has received the US FDA Breakthrough Device Designation by for Acolyte Image Guided Crossing and Re-Entry Catheter System, which is designed to facilitate the placement and positioning of guidewires and catheters within the coronary vasculature for the treatment of patients with coronary chronic total occlusions (CTOs) who continue to experience symptoms following medical therapy.

This breakthrough device is poised to significantly change the approach to treating coronary CTOs by providing real-time optical coherence tomography (OCT) visualization, enabling precise guidewire placement within the target vessel’s true lumen and subsequent revascularization. This designation recognizes the transformative potential of our technology in addressing a critical unmet need in the treatment of patients with coronary chronic total occlusions,” said Dr. John B. Simpson, Founder and CEO of Simpson Interventions.

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