Simpson Interventions’ Acolyte System Receives FDA Breakthrough Device Designation

April 11, 2024—Simpson Interventions, Inc. announced that its Acolyte image-guided crossing and re-entry catheter system has been granted Breakthrough Device designation by the FDA.

Acolyte 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. The device provides real-time optical coherence tomography visualization, enabling precise guidewire placement within the target vessel’s true lumen and subsequent revascularization.

The Acolyte image-guided crossing and re-entry catheter system aims to overcome the challenges of treating CTOs by providing clinicians with the device’s enhanced visualization and navigation capabilities, ultimately improving CTO crossing, procedural success rates, and patient outcomes.

Simpson Interventions stated it is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte image-guided crossing and re-entry catheter system.

John B. Simpson, MD, is Founder and CEO of Simpson Interventions.

“We are thrilled to receive FDA’s Breakthrough Device designation for our Acolyte image-guided crossing and re-entry catheter system,” commented Dr. Simpson in the company’s press release. “This designation recognizes the transformative potential of our technology in addressing a critical unmet need in the treatment of patients with coronary CTOs. We are committed to advancing the field of interventional cardiology and improving patient outcomes through innovation.”