Coronary Guide Wires

Ordering Info

Ordering information is available below for coronary guide wires, organized by category.

Coronary Workhorse Guide Wires

HI-TORQUE BALANCE™ Guide Wire

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE BALANCE™28000-HC3 cmStraightHydrophilic190 cm
HI-TORQUE BALANCE™28000J-HC3 cmJHydrophilic190 cm
HI-TORQUE BALANCE™28001-HC3 cmStraightHydrophilic300 cm
HI-TORQUE BALANCE™280003 cmStraightHydrophobic190 cm
HI-TORQUE BALANCE™28000J3 cmJHydrophobic190 cm
HI-TORQUE BALANCE™280013 cmStraightHydrophobic300 cm

 

HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE BALANCE MIDDLEWEIGHT™1001780-HC3 cmStraightHydrophilic190 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™1001780J-HC3 cmJHydrophilic190 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™1001782-HC3 cmStraightHydrophilic300 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™1001782J-HC3 cmJHydrophilic300 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™10017803 cmStraightHydrophobic190 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™1001780J3 cmJHydrophobic190 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™10017823 cmStraightHydrophobic300 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™1001782J3 cmJHydrophobic300 cm

 

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wire

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire LengthMarker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™10096603 cmStraightHydrophilic190 cmMarker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™1009660J3 cmJHydrophilic190 cmMarker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™10096613 cmStraightHydrophilic300 cmMarker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™1009661J3 cmJHydrophilic300 cmMarker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™10096623 cmStraightHydrophilic190 cmNo Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™1009662J3 cmJHydrophilic190 cmNo Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™10096633 cmStraightHydrophilic300 cmNo Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™1009663J3 cmJHydrophilic300 cmNo Marker

 

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ Guide Wire

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire LengthMarker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™10096643 cmStraightHydrophilic190 cmMarker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™1009664J3 cmJHydrophilic190 cmMarker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™10096653 cmStraightHydrophilic300 cmMarker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™1009665J3 cmJHydrophilic300 cmMarker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™10096663 cmStraightHydrophilic190 cmNo Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™1009666J3 cmJHydrophilic190 cmNo Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™10096673 cmStraightHydrophilic300 cmNo Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™1009667J3 cmJHydrophilic300 cmNo Marker

 

HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE BALANCE HEAVYWEIGHT™1000462H4.5 cmStraightHydrophilic190 cm
HI-TORQUE BALANCE HEAVYWEIGHT™1000462HJ4.5 cmJHydrophilic190 cm
HI-TORQUE BALANCE HEAVYWEIGHT™1000463H4.5 cmStraightHydrophilic300 cm
HI-TORQUE BALANCE HEAVYWEIGHT™1000463HJ4.5 cmJHydrophilic300 cm

 

HI-TORQUE FLOPPY II™ Family of Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE FLOPPY II™22339H2 cmStraightHydrophilic190 cm
HI-TORQUE FLOPPY II™22339M2 cmStraightHydrophobic190 cm
HI-TORQUE FLOPPY II™22339MJ2 cmJHydrophobic190 cm
HI-TORQUE FLOPPY II™22359M2 cmStraightHydrophobic300 cm
HI-TORQUE FLOPPY II™22359MJ2 cmJHydrophobic300 cm
HI-TORQUE FLOPPY II™22339M-90330 cmStraightHydrophobic190 cm
HI-TORQUE FLOPPY II™ ES22299H2 cmStraightHydrophilic190 cm
HI-TORQUE FLOPPY II™ ES22299M2 cmStraightHydrophobic190 cm
HI-TORQUE FLOPPY II™ ES22299M-90130 cmStraightHydrophobic190 cm
HI-TORQUE FLOPPY II™ ES22359M-9012 cmStraightHydrophobic300 cm

 

HI-TORQUE POWERTURN™ Family of Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE POWERTURN™10445943 cmStraightHydrophilic190 cm
HI-TORQUE POWERTURN™1044594J3 cmJHydrophilic190 cm
HI-TORQUE POWERTURN™10445953 cmStraightHydrophilic300 cm
HI-TORQUE POWERTURN™1044595J3 cmJHydrophilic300 cm
HI-TORQUE POWERTURN™ FLEX10445923 cmStraightHydrophilic190 cm
HI-TORQUE POWERTURN™ FLEX1044592J3 cmJHydrophilic190 cm
HI-TORQUE POWERTURN™ FLEX10445933 cmStraightHydrophilic300 cm
HI-TORQUE POWERTURN™ FLEX1044593J3 cmJHydrophilic300 cm
HI-TORQUE POWERTURN™ ULTRA FLEX10445903 cmStraightHydrophilic190 cm
HI-TORQUE POWERTURN™ ULTRA FLEX1044590J3 cmJHydrophilic190 cm
HI-TORQUE POWERTURN™ ULTRA FLEX10445913 cmStraightHydrophilic300 cm
HI-TORQUE POWERTURN™ ULTRA FLEX1044591J3 cmJHydrophilic300 cm

 

HI-TORQUE TURNTRAC™ Family of Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire LengthTip Coating
HI-TORQUE TURNTRAC™10200133 cmStraightHydrophilic190 cmCoated tip
HI-TORQUE TURNTRAC™1020013J3 cmJHydrophilic190 cmCoated tip
HI-TORQUE TURNTRAC™10200153 cmStraightHydrophilic300 cmCoated tip
HI-TORQUE TURNTRAC™10200143 cmStraightHydrophilic190 cmUncoated tip
HI-TORQUE TURNTRAC™1020014J3 cmJHydrophilic190 cmUncoated tip
HI-TORQUE TURNTRAC™10200163 cmStraightHydrophilic300 cmUncoated tip
HI-TORQUE TURNTRAC™ FLEX10200093 cmStraightHydrophilic190 cmCoated tip
HI-TORQUE TURNTRAC™ FLEX1020009J3 cmJHydrophilic190 cmCoated tip
HI-TORQUE TURNTRAC™ FLEX10200113 cmStraightHydrophilic300 cmCoated tip
HI-TORQUE TURNTRAC™ FLEX10200103 cmStraightHydrophilic190 cmUncoated tip
HI-TORQUE TURNTRAC™ FLEX1020010J3 cmJHydrophilic190 cmUncoated tip
HI-TORQUE TURNTRAC™ FLEX10200123 cmStraightHydrophilic300 cmUncoated tip

 

HI-TORQUE VERSATURN™ Guide Wire

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire LengthTip Coating
HI-TORQUE VERSATURN™10133173 cmStraightHydrophilic190 cmCoated tip
HI-TORQUE VERSATURN™1013317J3 cmJHydrophilic190 cmCoated tip
HI-TORQUE VERSATURN™10133193 cmStraightHydrophilic190 cmUncoated tip
HI-TORQUE VERSATURN™1013319J3 cmJHydrophilic190 cmUncoated tip

Coronary Specialty Guide Wires

HI-TORQUE WHISPER™ Family of Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE WHISPER™ MS1005357H3 cmStraightHydrophilic190 cm
HI-TORQUE WHISPER™ MS1005357HJ3 cmJHydrophilic190 cm
HI-TORQUE WHISPER™ MS1005359H3 cmStraightHydrophilic300 cm
HI-TORQUE WHISPER™ MS1005359HJ3 cmJHydrophilic300 cm
HI-TORQUE WHISPER™ ES1011834H3 cmStraightHydrophilic190 cm
HI-TORQUE WHISPER™ ES1011834HJ3 cmJHydrophilic190 cm
HI-TORQUE WHISPER™ ES1011835H3 cmStraightHydrophilic300 cm
HI-TORQUE WHISPER™ ES1011835HJ3 cmJHydrophilic300 cm
HI-TORQUE WHISPER™ LS1005351H3 cmStraightHydrophilic190 cm
HI-TORQUE WHISPER™ LS1005351HJ3 cmJHydrophilic190 cm
HI-TORQUE WHISPER™ LS1005353H3 cmStraightHydrophilic300 cm
HI-TORQUE WHISPER™ LS1005353HJ3 cmJHydrophilic300 cm

 

HI-TORQUE EXTRA S'PORT™ Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE EXTRA S'PORT™22225M3 cmStraightHydrophobic190 cm
HI-TORQUE EXTRA S'PORT™22225MJ3 cmJHydrophobic190 cm
HI-TORQUE EXTRA S'PORT™22235M3 cmStraightHydrophobic300 cm
HI-TORQUE EXTRA S'PORT™22235MJ3 cmJHydrophobic300 cm

 

HI-TORQUE ALL STAR™ Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE ALL STAR™10017403 cmStraightHydrophobic190 cm
HI-TORQUE ALL STAR™1001740J3 cmJHydrophobic190 cm
HI-TORQUE ALL STAR™10017413 cmStraightHydrophobic300 cm
HI-TORQUE ALL STAR™1001741J3 cmJHydrophobic300 cm

 

HI-TORQUE IRONMAN™ Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE IRONMAN™10013093 cmStraightHydrophobic190 cm
HI-TORQUE IRONMAN™1001309J3 cmJHydrophobic190 cm
HI-TORQUE IRONMAN™10013113 cmStraightHydrophobic300 cm
HI-TORQUE IRONMAN™1001311J3 cmJHydrophobic300 cm

 

HI-TORQUE CROSS-IT™ Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE CROSS-IT™ 100XT1003309H3 cmStraightHydrophilic190 cm
HI-TORQUE CROSS-IT™ 100XT1003309HJ3 cmJHydrophilic190 cm
HI-TORQUE CROSS-IT™ 100XT1003310H3 cmStraightHydrophilic300 cm
HI-TORQUE CROSS-IT™ 100XT1003310HJ3 cmJHydrophilic300 cm

 

HI-TORQUE WIGGLE™ Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE WIGGLE™22299M-W22 cmStraightHydrophobic190 cm
HI-TORQUE WIGGLE™22299M-W3030 cmStraightHydrophobic190 cm
HI-TORQUE WIGGLE™22359M-W22 cmStraightHydrophobic300 cm
HI-TORQUE WIGGLE™22399M-W3030 cmStraightHydrophobic300 cm

 

HI-TORQUE PILOT™ Family of Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE PILOT™ 501010480-H3 cmStraightHydrophilic190 cm
HI-TORQUE PILOT™ 501010480-HJ3 cmJHydrophilic190 cm
HI-TORQUE PILOT™ 501010483-H3 cmStraightHydrophilic300 cm
HI-TORQUE PILOT™ 501010483-HJ3 cmJHydrophilic300 cm
HI-TORQUE PILOT™ 1501010481-H3 cmStraightHydrophilic190 cm
HI-TORQUE PILOT™ 1501010481-HJ3 cmJHydrophilic190 cm
HI-TORQUE PILOT™ 1501010484-H3 cmStraightHydrophilic300 cm
HI-TORQUE PILOT™ 1501010484-HJ3 cmJHydrophilic300 cm
HI-TORQUE PILOT™ 2001010482-H3 cmStraightHydrophilic190 cm
HI-TORQUE PILOT™ 2001010482-HJ3 cmJHydrophilic190 cm
HI-TORQUE PILOT™ 2001010485-H3 cmStraightHydrophilic300 cm
HI-TORQUE PILOT™ 2001010485-HJ3 cmJHydrophilic300 cm

 

HI-TORQUE PROGRESS™ Family of Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE PROGRESS™ 140T10118403 cmStraightHydrophilic190 cm
HI-TORQUE PROGRESS™ 140T10118413 cmStraightHydrophilic300 cm
HI-TORQUE PROGRESS™ 200T10118423 cmStraightHydrophilic190 cm
HI-TORQUE PROGRESS™ 200T10118433 cmStraightHydrophilic300 cm
HI-TORQUE PROGRESS™ 4010118363 cmStraightHydrophilic190 cm
HI-TORQUE PROGRESS™ 4010118373 cmStraightHydrophilic300 cm
HI-TORQUE PROGRESS™ 8010118383 cmStraightHydrophilic190 cm
HI-TORQUE PROGRESS™ 8010118393 cmStraightHydrophilic300 cm
HI-TORQUE PROGRESS™ 12010118443 cmStraightHydrophilic190 cm
HI-TORQUE PROGRESS™ 12010118453 cmStraightHydrophilic300 cm

 

HI-TORQUE INFILTRAC™ Family of Guide Wires

ProductPart NumberTip RadiopacityTip ShapeDistal CoatingsWire Length
HI-TORQUE INFILTRAC™1030001J3 cmMicro-JHydrophilic190 cm
HI-TORQUE INFILTRAC™1030002J3 cmMicro-JHydrophilic300 cm
HI-TORQUE INFILTRAC™ PLUS1030003J3 cmMicro-JHydrophilic190 cm
HI-TORQUE INFILTRAC™ PLUS1030004J3 cmMicro-JHydrophilic300 cm

 

Data on file at Abbott.

MAT-2109383 v2.0

Important Safety Information
 

HI-TORQUE™ Guide Wires

rx-only-logo

INTENDED USE

All HI-TORQUE™ Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

INDICATIONS
Refer to the device label for any additional product-specific indications that may apply.

CONTRAINDICATIONS
HI-TORQUE™ Guide Wires Wires are not intended for use in the cerebral vasculature. Refer to the device label for any additional product-specific contraindications that may apply.

WARNINGS
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

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.

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.


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.

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.

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.

HI-TORQUE™ Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating.

Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

ADVERSE EVENTS
Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

MAT-2213672 v1.0

HI-TORQUE™ Guide Wires for PTCA, PTA, and Stents

rx-only-logo

INDICATIONS FOR USE: This HI-TORQUE™ Guide Wire is intended to facilitate the placement of balloon dilatation catheters 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.

CONTRAINDICATIONS: Not intended for use in the cerebral vasculature or with atherectomy devices.


WARNINGS:

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

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.

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 and the stent.


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.

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.

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.

HI-TORQUE™ Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp- edged object.

ADVERSE EVENTS

Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

MAT-2213674 v1.0

HI-TORQUE™ Guide Wires
for PTCA, PTA, and Stents

rx-only-logo

INDICATIONS FOR USE
This HI-TORQUE™ Guide Wire is 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 compatiblestent 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.

CONTRAINDICATIONS
Not intended for use in the cerebral vasculature.

WARNINGS
Not intended for use with atherectomy devices.

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

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.

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.

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.

Never attach the torque device to the modified portion of the proximal end of the extendible guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.

HI-TORQUE™ Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

ADVERSE EVENTS
Potential adverse events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

MAT-2104725 v2.0

HI-TORQUE TURNTRAC™
Guide Wire

rx-only-logo

INDICATIONS FOR USE

This HI-TORQUETM Guide Wire is intended to facilitate the delivery of catheter-based interventional devices during the following procedures:

• Percutaneous transluminal angioplasty (PTA)

• Percutaneous transluminal coronary angioplasty (PTCA)

This guide wire may also be used with compatible stent devices.

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.
 

CONTRAINDICATIONS

Not intended for use in the cerebral vasculature.
 

WARNINGS

Not intended for use with atherectomy devices.

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.
     

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.

This device should be used only by physicians trained in angiography and percutaneous transluminal coronary angioplasty (PTCA), and / or percutaneous transluminal angioplasty (PTA).

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

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.

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 DOCTM Guide Wire Extension.

HI-TORQUETM Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.
 

ADVERSE EVENTS

Potential adverse events associated with use ofthis device may include the following but not limited to:

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

MAT-2104727 v2.0

HI-TORQUE VERSATURN™ Guide Wire

rx-only-logo

INDICATIONS FOR USE

This HI-TORQUE™ Guide Wire is intended to facilitate the delivery of catheter-based interventional devices during the following procedures:

  • Percutaneous transluminal angioplasty (PTA)
  • Percutaneous transluminal coronary angioplasty (PTCA)

This guide wire may also be used with compatible stent devices.

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

CONTRAINDICATIONS
Not intended for use in the cerebral vasculature.


WARNINGS
Not intended for use with atherectomy devices.

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.

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.

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.

Never attach the torque device to the modified portion of the proximal end of the extendible guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.

HI-TORQUE™ Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

ADVERSE EVENTS
Potential adverse events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

MAT-2104726 v2.0

HI-TORQUE PROGRESS™ Guide Wire, HI-TORQUE PILOT™ Guide Wire for PTCA, PTA, Stents, CTO

rx-only-logo

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 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).

 

CONTRAINDICATIONS: Not intended for use in the cerebral vasculature or with atherectomy devices.


WARNINGS:

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

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.

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 PROGRESS™ family only:
 The HI- TORQUE PROGRESS™ family of guide wires has 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 a 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.

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.

Never attach the torque device to the modified portion of the proximal end of the extendible 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.

ADVERSE EVENTS

Potential Adverse Events associated with use of this device may include the following, but not limited to: perforation, dissection, occlusion, myocardial infarction, embolism and infection.

MAT-2213673 v1.0

HI-TORQUE WIGGLE™ Guide Wire

rx-only-logo

INTENDED USE
The HI-TORQUE WIGGLE™ Guide Wire is intended to facilitate the placement of the catheter by orienting the catheter tip during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and other interventional diagnostic or therapeutic procedures.
 

INDICATIONS
Refer to the device label for any additional product-specific indications which may apply.

CONTRAINDICATIONS
The HI-TORQUE WIGGLE™ Guide Wire is not intended for use in the cerebral vasculature.

Refer to the device label for any additional product-specific contraindications which may apply.

WARNINGS
This device is designed and intended for ONE-TIME USE ONLY. DO NOT RESTERILIZE AND / OR REUSE.

Observe all guide wire movement in the vessels. Before a guide wire is moved or torqued, the tip movement should be examined under fluoroscopy. Do not torque a guide wire without observing corresponding movement of the tip; otherwise, vessel trauma may occur.

Torquing a guide wire against resistance may cause guide wire damage and / or guide wire tip separation. Always advance or withdraw the guide wire slowly. Never push, auger, withdraw or torque a guide wire which meets resistance. Resistance may be felt and / or observed under fluoroscopy by noting any buckling of the guide wire tip. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.

If the wire tip becomes entrapped within the vasculature, DO NOT TORQUE THE GUIDE WIRE.

Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform all 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 not against the vessel wall. Failure to do so may result in vessel trauma upon guide wire exit of the device. Use the radiopaque marker of the interventional device to confirm position.

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 wires. Using a damaged 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. Test the system for any resistance prior to use. Mild to moderate resistance may be felt as the HI-TORQUE WIGGLE™ Guide Wire waves are advanced or retracted through the catheter. If severe resistance is encountered, it may be necessary to change to a catheter having a larger guide wire lumen.

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.

ADVERSE EVENTS
Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

MAT-2213675 v1.0

HI-TORQUE™ INFILTRAC
Guide Wire

rx-only-logo

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

MAT-2109381 v2.0