TaeWoong Medical USA Receives FDA 510(k) Clearance for SPAXUS™, Expanding Its EUS Therapeutic Portfolio

LOS ANGELES--(BUSINESS WIRE)--TaeWoong Medical USA today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Niti-S SPAXUS™ Stent, further strengthening its portfolio of endoscopic ultrasound (EUS)-guided therapeutic solutions.

The FDA determined the SPAXUS™ Stent to be substantially equivalent to legally marketed predicate devices, allowing for commercialization in the United States.

SPAXUS™ is a fully covered, self-expanding metallic stent designed to facilitate endoscopic ultrasound-guided transluminal drainage procedures. The device features a bi-flange design to support lumen apposition and help reduce the risk of migration, along with a silicone coating to minimize leakage and support removability.

The SPAXUS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage in the following procedures:

• Symptomatic pancreatic pseudocysts ≥ 6 cm in size and walled-off necrosis ≥ 6 cm in size.
• Gallbladder drainage in patients with acute cholecystitis who are at high risk for surgery.

In a pivotal clinical evaluation for the treatment of pancreatic pseudocysts, the device demonstrated outstanding safety and effectiveness, achieving a 97.1% clinical success rate with zero device-related serious adverse events reported. Additional extensive clinical data supports the stent's high safety and efficacy profile across all indicated procedures.

“This FDA clearance represents an important milestone for TaeWoong Medical USA as we continue to expand our advanced endoscopic solutions in the U.S. market,” said Minsoo Seo, CEO at TaeWoong Medical USA. “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 clearance, TaeWoong Medical USA continues to build on its growing EUS portfolio, offering physicians additional tools designed to improve procedural efficiency and patient outcomes.

About TaeWoong Medical USA

TaeWoong Medical USA is a fast-growing distributor of innovative gastrointestinal medical devices, committed to improving patient care across the United States. As the exclusive U.S. partner of TaeWoong Medical Co., Ltd. we offer a comprehensive portfolio including esophageal, biliary and colonic stents, RFA (radiofrequency ablation) systems and endoscopic accessories. Based in California, we focus on rapid delivery, clinical excellence and building strong relationships with healthcare professionals nationwide. Our mission is to bring world-class solutions to the U.S. healthcare market with a deep commitment to innovation, quality and service. Learn more at www.taewoongusa.com.