Device Dossier

HI-TORQUE PROGRESS PTCA Guide Wire - Catheter guide wire

Device Dossier for HI-TORQUE PROGRESS PTCA Guide Wire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Abbott…

Intended purpose

Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (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. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).

Functional description

These guidewire are designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The stainless steel core runs through the entire length of the wire. All wires have maximum diameter of 0.0140" and are provided in 190cm extendable and 300cm exchange lengths. The distal core segment of PROGRESS is offered in 5 configurations. Each config. is identical in design except for those design features that impact tip flexibility.

TGA Public Summary