Chronic total occlusions (CTOs) are prevalent in up to 31% of patients undergoing percutaneous coronary intervention (PCI),1 even though these lesions are seriously undertreated.2 Fortunately, successful PCIs for CTOs are steadily increasing — despite the increasing complexity of the lesions attempted — due in part to advances in guide wire technology.2
A penetration wire guide wire — the HI-TORQUE INFILTRAC™ Guide Wire, with its CTO indication† — is key to successfully penetrating the CTO cap* using the antegrade wire escalation (AWE) technique. The design of this specialized guide wire, including its enhanced technology and performance characteristics, all contribute to CTO procedural efficacy and efficiency.2
This guide wire’s unique micro-textured tipˆ:
Because the tip is uncoated, it also provides exceptional tactile feedback to the operator.†
There are two penetration powers available with the HI-TORQUE INFILTRAC guide wire, used with the antegrade wire escalation technique.
| HI‑TORQUE INFILTRAC™ Guide Wire | HI‑TORQUE INFILTRAC™ PLUS Guide Wire | |
|---|---|---|
| Tip Load* | 11 g | 14 g |
| Penetration Power* | 167 kg/in² | 224 kg/in² |
With either choice of guide wire, the tip is tapered to 0.009Ӡ to improve penetration capability. In addition to penetration power, the tapered, pre-shaped micro-J tip is a critical feature enabling CTO PCI success.
The HI-TORQUE INFILTRAC™ Guide Wire’s micro-J tip has a 25° angle extending 1 mm from the tip. This allows tip redirecting without compromising tip load nor penetration power.†
Penetration of challenging CTOs is due to a number of unique design features of the HI-TORQUE INFILTRAC™ Guide Wire:
Abbott’s proven guide wire design features are also incorporated into the design:†
| Description | Part Number | Tip Load (g)* | Penetration Power (kg/in²)* | Wire Length (cm) | Tip Diameter (in) | Tip Shape |
|---|---|---|---|---|---|---|
| HI-TORQUE INFILTRAC™ Guide Wire | 1030001J | 11 | 167 | 190 | 0.009 | Micro-J |
| 1030002J | 11 | 167 | 300 | 0.009 | Micro-J | |
| HI-TORQUE INFILTRAC™ PLUS Guide Wire | 1030003J | 14 | 224 | 190 | 0.009 | Micro-J |
| 1030004J | 14 | 224 | 300 | 0.009 | Micro-J |
^ US20200222067A1
* Tests performed by and data on file at Abbott.
† Data on file at Abbott.
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 also be used with compatible stent devices during therapeutic procedures. The guide wire may also 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 wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).
Not intended for use in the cerebral vasculature.
This device is not designed for use with atherectomy devices. The safety and effectiveness of the use of this HI-TORQUE™ Guide Wire with atherectomy devices is unestablished.
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and/or reuse. The safety and effectiveness of this device has not been established after being reprocessed for multiple uses.
This device has a hydrophilic coating at the distal end of the device for a length of 25.6 cm, and a silicone based hydrophobic coating at the proximal end for a length of 133 cm (on 190 cm wires) and 250 cm (on 300 cm wires), and a PTFE hydrophobic coating at the proximal end for a length of 156.5 cm (on 190 cm wires) and 266.5 cm (on 300 cm wires).
Please refer to section PREPARATION FOR USE for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or results in serious adverse events. The safety and effectiveness of the device has not been established, or is unknown, in vascular regions other than those specifically indicated.
This device contains stainless steel, nickel, chromium, fluoropolymers, tin, gold, silver and platinum that may cause allergic or hypersensitivity reactions. Persons allergic to these may suffer an allergic reaction to this guide wire. Prior to use on the patient, the patient should be counselled on the materials contained in the device and a thorough history of allergies must be discussed.
Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.
Do Not:
Do:
For the HI-TORQUE INFILTRAC™ Guide Wire family only: The HI-TORQUE INFILTRAC™ Guide Wire family have distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessel, observing the information in these instructions. The higher torque performance, stiffer distal ends, and/or higher advancement force may present higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels.
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and/or inaccurate torque response.
Confirm the compatibility of the guide wire diameter with the interventional device before actual use.
Please refer to the indication on the label and the Instructions for Use to confirm the appropriate vasculature that this guide wire may be used in. Failure to abide by the above recommendation may result in size mismatch of blood vessel and guide wire, which can result in vessel injury, such as, but not limited to, perforation, dissection, rupture, and avulsion.
Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement. It is recommended that the user determine the source of resistance, exercise caution when removing the device and/or other components as a unit and exchange the device for a new one to complete the procedure.
Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.
Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object. Manipulation, advancement, and/or withdrawal through a metal device may result in destruction and/or separation of the outer coating, which may cause coating material to remain in the vasculature. This in turn may lead to unintended adverse events requiring additional intervention.
When wet, a hydrophilic coating increases the lubricity of the guide wire surface.
Do not soak the device for longer than 4 hours when the device is not in use. Avoid pre-soaking devices for longer than instructed, as this may impact the coating performance.
The coating swells when exposed to aqueous media, but does not have any impact on the device use.
The integrity and performance of the device coating can be negatively impacted by preparation with incompatible media or solvents. Please take note of the following important recommendations:
Attempting to alter the shape of the devices by bending, twisting, or similar methods beyond instructed methods may compromise the coating integrity, and that damage to the coating may not always be noticeable to the naked eye.
Potential Adverse Events associated with use of this device may include the following, but not limited to:
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