Patients Treated in Trials Using Image-Guided Catheter Method Highlighted by Simpson
The Acolyte system, a revolutionary device designed by Simpson Interventions, is making strides in addressing the challenges of treating Chronic Total Occlusions (CTOs) in patients with coronary artery disease. This system is specifically designed to support revascularization within the target vessel's true lumen, offering a safe, predictable, and minimally invasive approach to cardiac treatments.
The U.S. Food and Drug Administration (FDA) has designated the Acolyte system as a breakthrough device, recognising its potential to significantly improve patient outcomes. The system is equipped with real-time Optical Coherence Tomography (OCT) visualization, a feature that aids in guidewire placement and revascularization.
Simpson Interventions is currently conducting a clinical trial for the Acolyte system. The trial is focused on assessing the safety and effectiveness of the system in treating CTOs with persistent symptoms following medical therapy. The first patients treated in the clinical trial are now being enrolled, marking a significant step towards understanding the system's performance in treating CTOs.
The Acolyte system is enrolled in the FDA Total Product Life Cycle Advisory Program (TAP), a programme that provides ongoing guidance and support to device manufacturers throughout the life cycle of their products.
While further details about the clinical trial, its focus, and its participants remain undisclosed, the Acolyte system's potential to improve the treatment of CTOs in patients with coronary artery disease is undeniably promising. As research continues, we look forward to learning more about this innovative device and its impact on cardiac care.
