Endorail includes two components to be used in combination called: Endorail Set and Endorail System. Endorail Set is disposable and includes the following elements:• Endorail Balloon Guide (EBG),• Endorail Solution Syringe (ESS),• Endorail Powder (EP),• Spike.Before the procedure, the operator prepares the syringe containing the ferromagnetic fluid using the ESS, the spike and the EP. The EBG is a balloon catheter that can be introduced as needed through the endoscope instrument channel during the colonoscopy, if the procedure becomes challenging. Endorail Set does not require to be pre-mounted and does not interfere with the normal examination process. The EBG is advanced beyond the colonoscope tip where the balloon is filled with the ferromagnetic fluid and magnetically anchored with the Endorail Handpiece (EH) placed on the patient’s abdomen. Once anchored, the colonoscope can be straightened and guided along the catheter. Afterward the EBG can be unlocked, deflated and retrieved.
A flexible tube with an inflatable balloon at its distal tip intended to be introduced through the working channel of a gastrointestinal endoscope (e.g., colonoscope, enteroscope) and filled with a ferromagnetic material, to facilitate magnetic coupling with an external magnet (not included) for magnetic anchoring or manipulation of the catheter/endoscope, for e.g., manual colonoscope straightening in cases of a difficult colonoscopy (also known as looping or twisting). It includes the ferromagnetic material, typically provided as a solution of iron particles; devices intended to support catheter function (e.g., balloon fill syringe) may be included. This is a single-patient reusable device.
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