AXIOS Stent With Electrocautery Enhanced Delivery System

Inclusion criteria

• Age between 18 and 75 years old, male or female
• Eligible for endoscopic intervention
• Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
• Symptomatic pancreatic pseudocyst having the following characteristics:

• Greater or equal to 6 cm in diameter (based upon the maximum cross-sectional area in the CT scan or transabdominal ultrasound).
• Adherent to bowel wall, and
• ≥70% fluid content
• 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 CT imaging study.

Exclusion criteria

• The fluid collection to be drained is an immature pseudocyst
• The fluid collection to be drained is a cystic neoplasm
• The fluid collection to be drained is a pseudoaneurysm
• The fluid collection to be drained is a duplication cyst
• The fluid collection to be drained is a non-inflammatory fluid collection
• There is more than one pseudocyst requiring drainage
• Abnormal coagulation:

• INR > 1.5 and not correctable
• presence of a bleeding disorder
• platelets < 50,000/mm3
• Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
• Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
• Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
• Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
• Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.