Sam Brusco, Associate Editor04.12.24
Simpson Interventions, a company that specializes in cardiovascular interventional devices, has been granted breakthrough device status from the U.S. Food and Drug Administration (FDA) for its Acolyte image-guided crossing and re-entry catheter system.
Acolyte was designed to facilitate guidewire and catheter placement and positioning in coronary vasculature to treat coronary chronic total occlusions (CTOs) in patients that keep experiencing symptoms after medical therapy. The device aims to change the approach to treatment of coronary CTOs via real-time optical coherence tomography (OCT) visualization, allowing precise guidewire placement in the target vessel’s true lumen and subsequent revascularization.
If a physician fails to cross a CTO, minimally invasive revascularization options like angioplasty and stent placement can’t be performed. Therefore, in the U.S., many CTO patients are instead sent for bypass surgery.
Acolyte aims to surmount these issues with a device that has enhanced visualization and navigation capabilities. Simpson Interventions hopes this will improve CTO crossing, procedural success rates, and outcomes.
"We are thrilled to receive FDA's Breakthrough Device Designation for our Acolyte Image Guided Crossing and Re-Entry Catheter System," said Dr. John B. Simpson, Ph.D., MD, founder and CEO of Simpson Interventions. "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."
Acolyte was designed to facilitate guidewire and catheter placement and positioning in coronary vasculature to treat coronary chronic total occlusions (CTOs) in patients that keep experiencing symptoms after medical therapy. The device aims to change the approach to treatment of coronary CTOs via real-time optical coherence tomography (OCT) visualization, allowing precise guidewire placement in the target vessel’s true lumen and subsequent revascularization.
If a physician fails to cross a CTO, minimally invasive revascularization options like angioplasty and stent placement can’t be performed. Therefore, in the U.S., many CTO patients are instead sent for bypass surgery.
Acolyte aims to surmount these issues with a device that has enhanced visualization and navigation capabilities. Simpson Interventions hopes this will improve CTO crossing, procedural success rates, and outcomes.
"We are thrilled to receive FDA's Breakthrough Device Designation for our Acolyte Image Guided Crossing and Re-Entry Catheter System," said Dr. John B. Simpson, Ph.D., MD, founder and CEO of Simpson Interventions. "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."