Simpson Interventions is highlighting the first patients treated in a clinical trial studying the performance of the company's Acolyte Image-Guided Crossing and Re-Entry Catheter System.
The study is assessing the safety and effectiveness of the system in treating chronic total occlusions (CTOs) with persistent symptoms following medical therapy.
The Acolyte system aims to overcome current challenges in treating CTOs in patients with coronary artery disease. It provides real-time optical coherence tomography (OCT) visualization to support guidewire placement within the target vessel's true lumen and revascularization.
The technology is designated by the U.S. Food and Drug Administration (FDA) as a breakthrough device and has been enrolled in the FDA Total Product Life Cycle Advisory Program (TAP).
Company leaders said the goal of the system is to provide a safe, predictable, and minimally invasive approach to cardiac treatments.
