AXIOS™

Stent and Electrocautery Enhanced Delivery System

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 pseudocysts and walled-off necrosis under EUS imaging guidance in the U.S., providing an endoscopic treatment option. Previous available technologies for endoscopic management of pancreatic pseudocysts were not originally designed or intended for this type of treatment.

*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.