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.
The stent features a bi-flange design to support lumen apposition and is silicone-coated to aid placement, reduce leakage, and allow for removal.
The Spaxus Stent is cleared for use in the endoscopic drainage of symptomatic pancreatic pseudocysts and walled-off necrosis that are 6 cm or larger.
It is also indicated for gallbladder drainage in patients with acute cholecystitis who are considered high risk for surgery.
In a clinical evaluation for pancreatic pseudocyst treatment, the stent achieved a clinical success rate of 97.1% with no serious adverse events attributed to the device, according to data provided by the company.
TaeWoong Medical also referenced additional clinical evidence demonstrating safety and efficacy across all relevant procedures.
TaeWoong Medical CEO Minsoo Seo said: “This FDA clearance represents an important milestone for TaeWoong Medical as we continue to expand our advanced endoscopic solutions in the US market.
“Spaxus provides physicians with a reliable option for EUS-guided drainage procedures and reinforces our commitment to innovation in minimally invasive GI care.”
With this latest FDA clearance, TaeWoong Medical adds to its EUS product line, offering healthcare professionals an additional tool for therapeutic endoscopy procedures.
TaeWoong Medical operates as a distributor of gastrointestinal medical devices and serves as the exclusive US partner of TaeWoong Medical. The company’s range includes devices and accessories for oesophageal, biliary and colonic procedures, as well as radiofrequency ablation systems.
