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The AXIOS™ Stent and Delivery System is indicated for use to facilitate transenteric endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size, with ≥ 70% fluid content that are adherent to the gastric or bowel wall. Once placed, the AXIOS 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 resolution.

The AXIOS™ Stent and Delivery System is an endoscopic device designed to deliver a fully-covered stent between a pancreatic pseudocyst and the gastrointestinal tract. The AXIOS™ Stent is a flexible, MR compatible, fully-covered self-expanding Nitinol stent preloaded within the AXIOS Delivery System. The AXIOS™ Delivery System is compatible with endoscopes equipped with a 3.7mm diameter or larger working channel. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for use during a single patient procedure. The AXIOS Stent and Delivery System are sterilized by a validated method of sterilization via Ethylene Oxide (EO).

The AXIOS Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, with ≥ 70% fluid content that are adherent to the bowel wall. Once placed, the AXIOS Stent functions as a 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 resolution.

The AXIOS Stent and Delivery System consists of two major components, the catheter-based delivery system and the implantable stent. The stent is a flexible, fully-covered. self-expanding Nitinol stent, which is preloaded within the catheter-based delivery system. The system is intended to cannulate the transgastric or transduodenal wall into a pancreatic pseudocyst for endoscopic drainage. The stent serves as a conduit for passive drainage of pseudocyst contents directly into the GI tract. The large lumen diameter provides a short path and may allow secure access to the pseudocyst interior for additional diagnostic or therapeutic procedures. The AXIOS Stent is designed with a duplicate "anchor" or "flange" on each end to achieve tissue apposition and prevent migration. The stent is radiopaque and is fully covered with silicone to prevent leakage, minimize tissue in-growth, and facilitate removal. The AXIOS Stent will be provided in two lumen diameters (10mm and 15mm) and one length (10mm). The AXIOS Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The AXIOS Delivery System is sized to fit within commercially available echoendoscopes with a working channel of 3.7 mm diameter or larger. The Delivery System catheter is 138 cm in working length and attached directly to the endoscope handle. The AXIOS Delivery System requires an access site of at least 10 Fr. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for use during a single patient procedure.

The XIumena NAVIX Access IDevice is intended for useras an accessory to cannulate the transgastric or transduodenal wall into a pancreativ oseudocyst. When it is visibly bulging into the gastrointestinal tractic furing endoscopic procedures

The NAVIX Access Device is a multi-lumen catheter device that enables the physician to create and dilate an access tract through adjacent tissues. The NAVIX Access Device is exchange-free in that it delivers multiple tools without the need to exchange these tools over a guidewire. The NAVIX Access Device includes a trocar, an anchor balloon, and a dilation balloon,