CTO-PCI Study Begins for Simpson’s Acolyte Catheter System

August 14, 2025—Simpson Interventions, Inc. announced that its Acolyte image-guided crossing and re-entry catheter system has been used to treat the first patients in the company’s pivotal trial assessing the safety and effectiveness of percutaneous coronary intervention (PCI) with the system to treat coronary chronic total occlusions (CTOs) with persistent symptoms after medical therapy.

According to the company, the Acolyte CTO-PCI Study, which is being conducted under an FDA investigational device exemption, is planned to treat a minimum of 103 lesions at up to 15 sites.

The Acolyte device is intended to provide real-time visualization of intravascular morphology with simultaneous intervention to potentially provide a more reliable and predictable tool to facilitate revascularization of CTOs. The technology has been granted the FDA Breakthrough Device designation and is enrolled in TAP, the FDA’s Total Product Life Cycle Advisory Program, noted Simpson Interventions.

Bill Nicholson, MD, was the primary operator on the first cases, which were conducted at Emory University Hospital in Atlanta, Georgia.

“Our team is thrilled to have successfully treated the first patients with the Acolyte system,” commented Dr. Nicholson, who is Director of Interventional Cardiology at Emory University. “The ability to clearly visualize the CTO in real-time and precisely position a guidewire with the same device potentially represents an important leap forward in efficiently and predictably treating coronary CTOs.”

The Principal Investigator for the Acolyte study is Wissam Jaber, MD, Medical Director of the Cardiac Catheterization Laboratory at Emory University Hospital.

Dr. Jaber stated, “We are pleased to be the first site to treat a patient in this important trial. CTOs have long been regarded as ‘the final frontier’ of PCI due to their inherent complexity and lack of suitable devices. The Acolyte system represents a promising approach to enable interventional cardiologists to more effectively, consistently, and safely treat these complex lesions, potentially allowing more patients to benefit from a minimally invasive PCI approach.”