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8mm×20mm stents:
The Niti-S SPAXUS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution.

10mm×20mm and 16mm×20mm stents:
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 provides stable lumen apposition and helps mitigate migration risk. The complete silicone coating helps prevent 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 Stent Delivery System (SDS) is a disposable, non-electrocautery system for the delivery and deployment of the stent at the target position. It is similar in design to the SDS used for the Esophageal TTS Stent (K240522).

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