AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study

Inclusion Criteria: * Age between 22 and 75 years old * Severe or moderately severe acute necrotizing pancreatitis, defined per the 2012 Revised Atlanta Classification. * WON resulting from necrotizing pancreatitis per contrast-enhanced CT with the following characteristics, per the 2012 Revised Atlanta Classification: * Heterogeneous with liquid and non-liquid density with varying degrees of loculations (some may appear homogeneous) * Well defined wall * Location-intrapancreatic and/or extrapancreatic * Infected WON or symptomatic sterile WON Note: WON-related symptoms may include: pain, fever, leukocytosis, failure to thrive or deterioration of overall heath score, gastric outlet obstruction (GOO), weight loss, biliary obstructive symptoms, systemic inflammatory response syndrome (SIRS), deteriorating organ function, chronic nausea, lethargy, and inability to eat or gain weight * Imaging suggestive of greater than 30% necrotic material * WON ≥ 6cm in size * Eligible for endoscopic intervention * Acceptable candidate for endoscopic transluminal drainage * Patient understands the study requirements and the treatment procedures and provides written Informed Consent * Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post imaging study Exclusion Criteria: * Pseudocyst * Cystic neoplasm * Untreated Pseudoaneurysm \> 1cm within the WON * More than one WON clearly separated and requiring drainage * WONs that req…