Simpson obtains FDA breakthrough device designation for Acolyte system

The Acolyte system assists in accurately placing guidewires and catheters within coronary vessels. Simpson Intervention's Acolyte Image Guided Crossing and Re-Entry Catheter System has received breakthrough device designation from the US Food and Drug Administration (FDA), ensuring prioritized review and swift interaction with FDA experts for feedback.

Designed to aid in treating coronary chronic total occlusions (CTOs), the device facilitates navigation through coronary vessels. CTOs involve complete blockage of coronary arteries, often necessitating minimally invasive treatments like angioplasty or stent implants. Simpson's system utilizes real-time optical coherence tomography (OCT) visualization to navigate blockages, potentially avoiding invasive bypass surgery.

The Acolyte system aims to enhance CTO crossing and procedure success rates. In the global cardiac catheter market valued at $1.3 billion in 2021, the US accounted for $566 million, with Terumo and Teleflex holding the leading market shares. Additionally, Avinger offers the Tigereye ST image-guided CTO crossing device for peripheral vessels, launched commercially in September last year. Other players include Boston Scientific, Cordis, and Medtronic.