Endorail Set

Primary DI

08057502310115

Brand

Endorail Set

Company

ENDOSTART SRL

Model

ESETGEN2V02A

Catalog number

ESETGEN2V02A

Device description

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.

Published

2024-10-16

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Rx

true

OTC

false

Sterile

false

Single use

true