US-based TaeWoong Medical has secured the US Food and Drug Administration (FDA) clearance to commercialise the Niti-S Spaxus Stent, expanding its range of endoscopic ultrasound (EUS)-guided therapeutic solutions.

The regulatory decision allows the stent to be marketed within the US after the FDA determined it is substantially equivalent to relevant predicate devices already available on the market.

According to the TaeWoong Medical, the fully covered, self-expanding metallic device is intended to aid EUS drainage procedures.