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The AXIOS Stent and Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transquodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.

The AXIOS Stent and Electrocautery-Enhanced Delivery system is designed to help facilitate the transgastric or transduodenal endoscopic drainage of the gallbladder. The AXIOS Stent remains identical to the stents cleared previously per K220112. The AXIOS Stent is a flexible, magnetic resonance conditional, fully covered, self-expanding, braided nitinol stent, which comes preloaded into the delivery system. The AXIOS stent is designed with two flanges, one on each end, to prevent migration and to enable tissue plane apposition and a "saddle" in between the flanges to span the tissue implant distance. The stent is fully covered with silicone to prevent leakage, discourage tissue in-growth within the nitinol woven braid, and facilitate removal. The AXIOS Electrocautery-Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS™ Stent. The AXIOS™ Electrocautery-Enhanced Delivery System is designed to be used in the gastrointestinal tract with commercially available echoendoscopes with a 3.7 mm diameter or larger working chamel and is compatible with commercially available 0.035-inch insulated endoscopic guidewires. The Electrocautery-Enhanced Delivery System connects with an off-the-shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2.