The Acolyte system helps with the placement and positioning of guidewires and catheters within the coronary vessels. Image credit: Shutterstock/Amel Uzunovic.

The US Food and Drug and Administration (FDA) has granted breakthrough device designation to Simpson Intervention’s Acolyte Image Guided Crossing and Re-Entry Catheter System.

The US-based company will now be in line for prioritised review for the device’s submission and will also be able to interact quickly with FDA experts to discuss feedback during the premarket review phase.

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Simpson’s device is designed to help surgeons during procedures to treat coronary chronic total occlusions (CTOs). The Acolyte system helps with the placement and positioning of guidewires and catheters within the coronary vessels.

CTO is the complete blockage of one or more coronary arteries. Surgeons use catheters to pass through the blockage to then perform minimally invasive treatments such as angioplasty or stent implants. Simpson states that its device can help avoid invasive bypass surgery by facilitating navigation capabilities to the blockage via real-time optical coherence tomography (OCT) visualisation.

Simpson states its Acolyte system can improve CTO crossing as well as the success of procedures.

The global cardiac catheter market was estimated to be worth $1.3bn in 2021. The US comprised $566m of the global market, with Terumo and Teleflex occupying the two leading market shares. 

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Simpson’s CEO John Simpson said: “This designation recognises the transformative potential of our technology in addressing a critical unmet need in the treatment of patients with coronary chronic total occlusions.”

Also in the space is Avinger with its Tigereye ST image-guided CTO crossing device for peripheral vessels. The US company commercially launched the system in September last year. Boston Scientific, Cordis, and Medtronic also have systems that facilitate crossing CTOs.