FDA grants 510(k) clearance for the BOSS CSC Support Catheter

Jun 2, 2022

Galway-based Marvao Medical Devices is pleased to announce U.S. Food and Drug Administration (FDA) 510(k) clearance of the BOSScsc® Support Catheter. The BOSS Support Catheter facilitates guidewire placement across complex arterial lesions in the lower leg.


The BOSS Support Catheter was designed in collaboration with Dr Jihad Mustapha, a pioneering clinician recognised for his ground-breaking work in developing new approaches to the treatment of patients suffering from Critical Limb Ischemia, or CLI.  The device was finalised in further collaboration with Iatri Devices, a medical device company based in Columbus OH, who now has an exclusive global licence for Commercialisation of the BOSS product line. Receipt of this 510k puts the BOSS on track for a US launch in Q1 2023.