The Medtronic ProdiGI™ traction wire is indicated to grasp tissue within the esophagus, stomach, and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.
The Medtronic ProdiGI™ traction wire is contraindicated for use in patients with known or suspected varices or other structures at risk of significant bleeding at the targeted deployment location.
Potential complications include:
- irritation or injury to the mucosa
- device fragments in patient
- tissue damage
- allergic reaction
- chemical exposure
- mucosal laceration
- minor acute bleeding
- major bleeding
- transfusion secondary to major bleeding
- perforation and secondary complications related to perforation
- surgery or secondary intervention to correct perforation
- tumor seeding
- additional complications associated with an endoscopic submucosa dissection procedure