The Niti-S SPAXUS Stent is a fully covered, self-expanding metallic stent designed for the indications listed below.The Niti-S SPAXUS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size that are adherent to the gastric or bowel wall. Once placed, the Niti-S SPAXUS Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution. The Niti-S SPAXUS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.The Niti-S SPAXUS Stent is a fully covered, self-expanding metallic stent. The stent is constructed from nickel-titanium alloy (nitinol), which provides flexibility, durability, and self-expansion properties. Its bi-flange design ensures stable lumen apposition and minimizes the risk of migration. A complete silicone coating prevents leakage during drainage and facilitates the safe removal of the device. Radiopaque markers made of platinum/iridium and stainless steel enhance visibility under fluoroscopic guidance, aiding precise placement and monitoring. The device is provided sterile to the end user and has a 2-year shelf-life
A non-bioabsorbable tube intended to be endoscopically implanted transmurally between the gastrointestinal (GI) tract and a pancreatic pseudocyst or the biliary tract for drainage. It is a flanged stent-like structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone). It is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices to assist implantation, with or without electrosurgical functionality, may be included with the device.
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