Device Dossier
HI-TORQUE INFILTRAC Guide Wire with Hydrophilic Coating - Catheter guide wire
Device Dossier for HI-TORQUE INFILTRAC Guide Wire with Hydrophilic Coating - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use,…
- GMDN category: 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
A 304V stainless steel core yields desired support and performance. The hydrophilic distal end includes a series of tapered grinds and a parabolic grind to reduce the diameter and stiffness of the distal core. Modified proximal end allows attachment of DOC guide wire extension to facilitate exchange of interventional devices. Proximal markers aid in gauging guide wire position relative to guiding catheter tip. Distal radiopaque markers act as references in determining lesion length.