Device Dossier

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath - Catheter, intravascular, guiding

Device Dossier for CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III,…

Intended purpose

The VIZIGO 8.5F Steerable Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The sheath curve can be visualized when used with compatible CARTO EP Navigation Systems.

Functional description

Designed to provide accessibility and maneuverability in the cardiac anatomy. It is equipped with an integrated steering mechanism allowing for bi-directional deflection. It has 4 electrodes on the outer sheath to interface with compatible navigation systems to allow the visualization of the sheath.

TGA Public Summary