EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

A prospective, single arm, open label, multi-center, trial to evaluate the safety and
effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct
endoscopic necrosectomy with walled off pancreatic necrosis (WOPN). Total enrollment 30
subjects with at least 15 enrolled in the US.

Subjects will be debrided with the EndoRotor either at the time of stent placement or post
placement at Investigator's discretion with a maximum of 4 EndoRotor procedures. A minimum of
2 days is required between each EndoRotor procedure and all procedures need to be completed
within a 14 (+7/-0) day period. Follow up is completed 21 (+/- 7) days after last EndoRotor
debridement procedure.

Inclusion Criteria:

1. Subjects who are >22; inclusive of males and females.

2. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an
indication to undergo endoscopic necrosectomy after having undergone EUS-guided
drainage

3. Imaging suggestive of greater than or equal to 30% necrotic material

4. Walled off pancreatic necrosis size ≥6 cm and ≤22cm

5. Subject can tolerate repeated endoscopic procedures

6. Subject capable of giving informed consent.

7. Subjects with the ability to understand the requirements of the study, who have
provided written informed consent, and who are willing and able to return for the
required follow-up assessments through 21 (+/- 7) days, as indicated.

Exclusion Criteria:

1. Subject unable to give informed consent.

2. Subject is unwilling to return for repeated endoscopies.

3. Documented Pseudoaneurysm > 1cm within the WOPN

4. Intervening gastric varices or unavoidable blood vessels within the access tract
(visible using endoscopy or endoscopic ultrasound).

5. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for
the procedure

6. Any condition that in the opinion of the investigator would create an unsafe clinical
situation that would not allow the patient to safely undergo an endoscopic procedure
(lack of medical clearance).

7. Pregnant or lactating women or women of childbearing potential who do not employ a
reliable method of contraception as judged by the Investigator, and/or are not willing
to use reliable contraception for the duration of study participation.

8. Patient is known to be currently enrolled in another investigational trial that could
interfere with the endpoint analyses of this trial.