AXIOS™AXIOS™ Stent and Electrocautery Enhanced Delivery System 6mmx8mm

The AXIOS™ Stent and Electrocautery Enhanced Delivery System* is the first and currently the only stent indicated for transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocyst and walled off necrosis under EUS imaging guidance in the U.S. The cautery-enhanced access and delivery catheter is advanced through the tissue creating a translumenal conduit between the stomach or duodenal wall and the pancreatic pseudocyst where the pre-loaded stent is deployed to provide drainage.

Stent Design

• Proprietary one-step combined diathermic ring and cut-wire provides access into target tissue
• MRI conditional, fully covered self-expanding metal stent pre-loaded in the delivery catheter
• Perpendicular flanges secure tissue layers and help prevent migration
• Three sizes available, with the largest featuring a 20mm lumen for drainage
• Large diameter lumen apposition stent enables drainage allowing passage of the endoscope through the stent for additional therapeutic procedures including cystoscopy, irrigation and debridement

*The AXIOS Stent and Delivery System and the AXIOS Electrocautery Enhanced Stent and Delivery System Indications for Use: The AXIOS Stent and Delivery System and the AXIOS Electrocautery Enhanced Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >/= 6cm in size and walled-off necrosis >/=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 or walled-off necrosis resolution.