Indications, Safety, and Warnings

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.

Contraindications

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

Potential complications include:

irritation or injury to the mucosa
device fragments in patient
tissue damage
allergic reaction
chemical exposure
fever
mucosal laceration
minor acute bleeding
major bleeding
transfusion secondary to major bleeding
infection
perforation and secondary complications related to perforation
surgery or secondary intervention to correct perforation
aspiration
peritonitis
tumor seeding
death
additional complications associated with an endoscopic submucosa dissection procedure

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ProdiGI™ Traction Wire

Indications for use

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