Simpson Interventions Receives FDA Breakthrough Device Designation for Acolyte™ Image Guided Crossing and Re-Entry Catheter System

• Designation expedites the review of medical technologies that can improve the lives of patients with life-threatening or debilitating diseases or conditions
• The Acolyte System is intended to provide interventional cardiologists with a more reliable and predictable tool to facilitate revascularization of chronic total occlusion (CTO)
• Sixteen to twenty percent of patients with coronary artery disease have CTOs

CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced that its groundbreaking Acolyte Image Guided Crossing and Re-Entry Catheter System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

The Acolyte Image Guided Crossing and Re-Entry Catheter System is designed to facilitate the placement and positioning of guidewires and catheters within the coronary vasculature for the treatment of patients with coronary chronic total occlusions (CTOs) who continue to experience symptoms following medical therapy. This breakthrough device is poised to significantly change the approach to treating coronary CTOs by providing real-time optical coherence tomography (OCT) visualization, enabling precise guidewire placement within the target vessel’s true lumen and subsequent revascularization.

According to the Journal of the American College of Cardiology: Cardiovascular Interventions, sixteen to twenty percent of patients with coronary artery disease have CTOs¹, which occur when a coronary artery is completely blocked by plaque buildup, posing significant challenges for interventional cardiologists who struggle to traverse these lesions with current standard of care options. If a physician fails to cross a CTO, minimally invasive revascularization options such as angioplasty and stent placement cannot be performed. Hence, in the US, many CTO patients are instead sent for bypass surgery. The Acolyte Image Guided Crossing and Re-Entry Catheter System aims to overcome these challenges by providing clinicians with this breakthrough device that has enhanced visualization and navigation capabilities, ultimately improving CTO crossing, procedural success rates, and patient 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, PhD, 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.”

The FDA’s Breakthrough Device Designation is granted to medical devices that offer potential advantages over existing technologies for the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This designation expedites the development, assessment, and review process, enabling patients to gain access to innovative medical technologies more quickly.

Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company looks forward to bringing this revolutionary technology to clinicians, and patients in need.

For more information about Simpson Interventions and its innovative medical technologies, please visit www.simpsonint.com.

About Simpson Interventions:

Simpson Interventions is a leading medical technology company committed to addressing unmet clinical needs in cardiovascular diseases through technological innovations in visual-guidance, enhanced intelligence, and electromechanical automation for minimally invasive percutaneous intervention.

For more information: www.simpsonint.com

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¹ https://www.jacc.org/doi/10.1016/j.jcin.2021.09.027

Contacts

Steve Kelly

Simpson Interventions

Email: stevek@simpsonint.com