Simpson Interventions announced completion of the first cases in its pivotal investigational device exemption trial for the Acolyte catheter system. The study evaluates the safety and effectiveness of the image-guided crossing and re-entry catheter for coronary chronic total occlusions. CTOs occur when plaque completely blocks a coronary artery, posing significant treatment challenges. The Acolyte system is designed to help cardiologists visualize CTOs in real time and accurately position a guidewire using a single device. Current treatment limitations mean many CTO patients undergo bypass surgery or receive only medical therapy. If a guidewire cannot cross a CTO, minimally invasive options like angioplasty and stenting are not possible. The device aims to improve procedural success rates and expand treatment options for these patients. CEO Dr. Joseph Knight said the technology could deliver safer, more predictable, and minimally invasive outcomes. He added that the system has the potential to benefit cardiologists, hospitals, payers, and patients alike.