AXIOS Stent With Electrocautery Enhanced Delivery System

Exclusion Criteria

• •1. The fluid collection to be drained is an immature pseudocyst
• •2. The fluid collection to be drained is a cystic neoplasm
• •3. The fluid collection to be drained is a pseudoaneurysm
• •4. The fluid collection to be drained is a duplication cyst
• •5. The fluid collection to be drained is a non-inflammatory fluid collection
• •6. There is more than one pseudocyst requiring drainage
• •7. Abnormal coagulation:
• •* INR \> 1.5 and not correctable
• •* presence of a bleeding disorder
• •* platelets \< 50,000/mm3
• •8. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
• •9. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
• •10. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
• •11. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
• •12. 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.