Simpson Interventions announced this week that it received FDA breakthrough designation for its Acolyte image-guided crossing and re-entry catheter system.
Campbell, California-based Simpson Interventions designed Acolyte to facilitate the placement and positioning of guidewires and catheters within the coronary vasculature to treat patients with coronary chronic total occlusions (CTOs) who continue to have symptoms after therapy.
“We are thrilled to receive FDA’s breakthrough device designation for our Acolyte image guided crossing and re-entry catheter system,” Founder and CEO Dr. John Simpson said in a news release. “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. We are committed to advancing the field of interventional cardiology and improving patient outcomes through innovation.”
The company says the device would change the approach to treating coronary CTOs using real-time optical coherence tomography (OCT) visualization. OCT visualization allows for more precise guidewire placement within the target vessel’s true lumen and subsequent revascularization.
