CARDIOVASCULAR
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State-of-the-Art Tip Technology

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

Micro-Textured Tipˆ: For CTO Passage

This guide wire’s unique micro-textured tipˆ:

  • Provides excellent traction*
  • Can penetrate even resistant proximal CTO caps

Because the tip is uncoated, it also provides exceptional tactile feedback to the operator.

The micro-textured tip surface design on the HI-TORQUE INFILTRAC guide wire enables penetration of resistant proximal CTO caps.

Tapered Tip: For High Penetration Capabilities

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 0.009” 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 wires’ tapered tip enables excellent penetration: either 167 kg/in2 or 224 kg/in².


Pre-Shaped Micro-J Tip

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.

The 25-degree angle on the HI-TORQUE INFILTRAC J-tip both aids in steering and enables CTO penetration.


Unique Guide Wire Design

Penetration of challenging CTOs is due to a number of unique design features of the HI-TORQUE INFILTRAC™ Guide Wire:

  • Micro-textured tip^ to engage the CTO cap*
  • Tapered, pre-shaped tip for high penetration*
  • Uncoated tip for tactile feedback

Abbott’s proven guide wire design features are also incorporated into the design:

  • DURASTEEL stainless steel for needed support
  • Hydrophilic coating (excluding the tip) for lubricity and ease of movement within a microcatheter
  • Parabolic core grind for excellent torque response
The HI-TORQUE INFILTRAC guide wire incorporates unique features new to this guide wire, as well as proven features of other Abbott guide wires.

Ordering Information

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.

References

  1. New Program Targets Coronary Artery Chronic Total Occlusions, posted September 2017. Retrieved on 1/21/21 from https://www.englewoodhealth.org/hvadvisor-new-program-targets-coronary-artery-chronic-total-occlusions.
  2. US Cardiology Review 2020;14:e11. Retrieved on 1/21/21 from https://doi.org/10.15420/usc.2020.10.
Important Safety Information

IMPORTANT SAFETY INFORMATION

rx-only-logo HI-TORQUE INFLITRAC™
Guide Wire

INDICATIONS FOR USE

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).

CONTRAINDICATIONS

Not intended for use in the cerebral vasculature.

WARNINGS

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:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.
  • Deploy a stent such that it will entrap the wire between the vessel wall and the stent.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.
  • Consider that if a secondary wire is placed in a bifurcation branch, this wire may need to be retracted prior to stent deployment because there is additional risk that the secondary wire may become entrapped between the vessel wall and the stent.

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.


PRECAUTIONS

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:

  • Avoid wiping the device with dry gauze as this may damage the device coating.
  • Avoid excessive wiping of the coated device.
  • Avoid using alcohol, antiseptic solutions, or other solvents (e.g., use of medications and rotoflush) to pre-treat the device because this may cause unpredictable changes in the coating which could negatively affect the safety and performance of the guide wire.

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.

ADVERSE EVENTS

Potential Adverse Events associated with use of this device may include the following, but not limited to:

  • Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials, and drug reactions to anticoagulation, or antiplatelet drugs
  • Perforation
  • Dissection
  • Bleeding
  • Occlusion
  • Myocardial infarction
  • Embolism
  • AV fistula
  • Infection
  • Vasoconstriction
  • Vasospasm
  • Hypotension
  • Hypertension
  • Death

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