The U.S. Food and Drug Administration (FDA) has granted Simpson Interventions' Acolyte Image Guided Crossing and Re-Entry Catheter system Breakthrough Device Designation.
The system facilitates the placement and positioning of guidewires and catheters within the coronary vasculature for treating patients with coronary chronic total occlusions who continue to experience symptoms following medical treatment. It provides real-time optical coherence tomography visualization, supporting effective guidewire placement within the target vessel's true lumen and subsequent revascularization.
Simpson Interventions said it is working with the FDA to advance the development and regulatory review of the system and make the technology available for clinicians.
