US-based TaeWoong Medical has received FDA clearance to commercialise the Niti-S Spaxus Stent, expanding its range of endoscopic ultrasound (EUS)-guided therapeutic solutions. The decision means the stent is substantially equivalent to existing predicate devices and is approved for use in the endoscopic drainage of symptomatic pancreatic pseudocysts and walled-off necrosis that are 6cm or larger. The device also has a clinical success rate of 97.1% and no serious adverse events attributed to the device. The approval adds to Tae Woong Medical's EUS product line, offering healthcare professionals an additional tool for therapeutic endoscopy procedures.