Device Dossier

HI-TORQUE INFILTRAC PLUS Guide Wire with Hydrophilic Coating - Catheter guide wire

Device Dossier for HI-TORQUE INFILTRAC PLUS Guide Wire with Hydrophilic Coating - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use,…

Intended purpose

This guide wire is intended to facilitate delivery of catheter-based interventional devices during PTCA and PTA. This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. It may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO). It is a single use device. Not intended for use in the cerebral vasculature.

Functional description

The guide wire contains a 304V stainless steel core to yield the desired support and performance. The guide wire's hydrophilic distal end includes a series of tapered grinds and a parabolic grind which reduce diameter and stiffness of the distal core. The tip is J-shaped with a 14 g tip load. Modified proximal end allows attachment of guide wire extension extending the working length to facilitate exchange of interventional devices. Proximal and distal markers aid in gauging guide wire position.

TGA Public Summary