Guide Wire Families
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LEADING THE WAY IN GUIDE WIRE TECHNOLOGY.

EXPLORE ABBOTT'S GROWING PORTFOLIO OF WORKHORSE AND SPECIALTY GUIDE WIRES.

 

Frontline Workhorse guide wires are designed to be flexible, have a soft tip, and provide enough support to deliver most interventional devices.

CORE
MATERIAL

COVER TYPE
OR COILS

TIP
STYLE

COATINGS

TIP
LOAD (g)*

NITINOL

HI-TORQUE TURNTRAC

  • Responsease Parabolic Core Grind

Elastinite
Nitinol

Bare Coils

Core-To-Tip

Hydrophilic

0.8

HI-TORQUE TURNTRAC FLEX

  • Responsease Parabolic Core Grind

Elastinite
Nitinol

Bare Coils

Core-To-Tip

Hydrophilic

0.6

HI-TORQUE VERSATURN

  • Responsease Parabolic Core Grind

Elastinite
Nitinol

Bare Coils

Core-To-Tip

Hydrophilic

0.8

HI-TORQUE BALANCE MIDDLEWEIGHT

Elastinite
Nitinol

Bare Coils

Shaping
Ribbon

Hydrophilic or
Hydrophobic

0.6

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL

Elastinite
Nitinol

Intermediate
Polymer Sleeve

Shaping
Ribbon

Hydrophilic

0.6

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II

Elastinite
Nitinol

Intermediate
Polymer Sleeve

Shaping
Ribbon

Hydrophilic

0.7

HI-TORQUE BALANCE MIDDLEWEIGHT ELITE

  • Responsease Parabolic Core Grind

Elastinite
Nitinol

Bare Coils

Core-To-Tip

Hydrophilic

0.8

STAINLESS STEEL

HI-TORQUE FLOPPY II

Stainless Steel

Bare Coils

Shaping Ribbon

Hydrophilic or
Hydrophobic

0.4

HI-TORQUE POWERTURN

  • Responsease Parabolic Core Grind

DURASTEEL
Stainless Steel

Bare Coils

Core-To-Tip

Hydrophilic

0.9

HI-TORQUE POWERTURN FLEX

  • Responsease Parabolic Core Grind

DURASTEEL
Stainless Steel

Bare Coils

Core-To-Tip

Hydrophilic

0.9

HI-TORQUE POWERTURN ULTRAFLEX

  • Responsease Parabolic Core Grind

DURASTEEL
Stainless Steel

Bare Coils

Core-To-Tip

Hydrophilic

0.9

HI-TORQUE ADVANCE

DURASTEEL

Bare Coils

Core-To-Tip

Hydrophilic or
Hydrophobic

1.0

* Tests performed by and data on file at Abbott

Specialty guide wires are designed to provide increasing tip stiffness and excellent torque response for superb crossing performance.

CORE
MATERIAL

COVER TYPE
OR COILS

TIP
STYLE

COATINGS

TIP
LOAD (g)*

SOFT POLYMER

HI-TORQUE WHISPER MS

  • Responsease Parabolic Core Grind

DURASTEEL

Full Polymer

Core-To-Tip

Hydrophilic

1.0

HI-TORQUE WHISPER ES

  • Responsease Parabolic Core Grind
  • Enhanced Distal Support Compared to HI-TORQUE WHISPER MS

DURASTEEL

Full Polymer

Core-To-Tip

Hydrophilic

1.2

HI-TORQUE PILOT 50

  • Responsease Parabolic Core Grind
  • CTO Indicated

DURASTEEL

Full Polymer

Core-To-Tip

Hydrophilic

1.5

SUPPORT

HI-TORQUE BALANCE HEAVYWEIGHT

ELASTINITE
Nitinol

Bare Coils

Shaping Ribbon

Hydrophilic

0.8

HI-TORQUE EXTRA S'PORT

Stainless Steel

Bare Coils

Core-To-Tip

Hydrophobic

0.9

HI-TORQUE ALL STAR

Stainless Steel

Intermediate Polymer Sleeve

Core-To-Tip

Hydrophobic

0.8

HI-TORQUE IRON MAN

Stainless Steel

Bare Coils

Core-To-Tip

Hydrophilic

1.0

FULL POLYMER COVER

HI-TORQUE PILOT 150

  • Responsease Parabolic Core Grind
  • CTO Indicated

DURASTEEL

Full Polymer

Core-To-Tip

Hydrophilic

2.7

HI-TORQUE PILOT 200

  • Responsease Parabolic Core Grind
  • CTO Indicated

DURASTEEL

Full Polymer

Core-To-Tip

Hydrophilic

4.1

TAPERED TIP

HI-TORQUE PROGRESS 140T

  • CTO Indicated
  • Tip Tapers to 0.0105"

DURASTEEL

Intermediate Polymer Sleeve With Exposed Tip Coils

Core-To-Tip

Hydrophilic

12.5

HI-TORQUE PROGRESS 200T

  • CTO Indicated
  • Tip Tapers to 0.009"

DURASTEEL

Intermediate Polymer Sleeve With Exposed Tip Coils

Core-To-Tip

Hydrophilic

13.0

STAINLESS STEEL

HI-TORQUE CROSS-IT 100XT

Stainless Steel

Bare Coils

Core-To-Tip

Hydrophilic

1.7

HI-TORQUE WIGGLE

Stainless Steel

Bare Coils

Shaping Ribbon

Hydrophilic

0.3

STRAIGHT TIP

HI-TORQUE PROGRESS 40

  • Responsease Parabolic Core Grind
  • CTO Indicated

DURASTEEL

Intermediate Polymer Sleeve With Exposed Tip Coils

Core-To-Tip

Hydrophilic

4.8

HI-TORQUE PROGRESS 80

  • Responsease Parabolic Core Grind
  • CTO Indicated

DURASTEEL

Intermediate Polymer Sleeve With Exposed Tip Coils

Core-To-Tip

Hydrophilic

9.7

HI-TORQUE PROGRESS 120

  • Responsease Parabolic Core Grind
  • CTO Indicated

DURASTEEL

Intermediate Polymer Sleeve With Exposed Tip Coils

Core-To-Tip

Hydrophilic

13.9

* Tests performed by and data on file at Abbott

Ordering information for select Coronary Abbott Guide Wires.

FRONTLINE WORKHORSE

Wire Name Part Number Tip Shape Wire Length (cm) Additional Detail
HT TURNTRAC 1020013 Straight 190 Coated tip
1020014 Straight 190 Uncoated tip
1020015 Straight 300 Coated tip
1020016 Straight 300 Uncoated tip
HT TURNTRAC FLEX 1020009 Straight 190 Coated tip
1020010 Straight 190 Uncoated tip
1020011 Straight 300 Coated tip
1020012 Straight 300 Uncoated tip
HT POWERTURN 1044594 Straight 190 -
1044594J J 190 -
1044595 Straight 300 -
1044595J J 300 -
HT POWERTURN FLEX 1044592 Straight 190 -
1044592J J 190 -
1044593 Straight 300 -
1044593J J 300 -
HT POWERTURN ULTRAFLEX 1044590 Straight 190 -
1044590J J 190 -
1044591 Straight 300 -
1044591J J 300 -
HT VERSATURN 1013317 Straight 190 Hydrophilic coated tip
1013317J J 190 Hydrophilic coated tip
1013319 Straight 190 Uncoated tip
1013319J J 190 Uncoated tip
HT ADVANCE 1044588 Straight 190 -
1044588J J 190 -
1044589 Straight 300 -
1044589J J 300 -
HT BALANCE MIDDLEWEIGHT 1001780-HC Straight 190 -
1001780J-HC J 190 -
1001782-HC Straight 300 -
1001782J-HC J 300 -
HT BALANCE MIDDLEWEIGHT ELITE 1011880 Straight 190 -
1011880J J 190 -
1011881 Straight 300 -
1011881J J 300 -
HT BALANCE
MIDDLEWEIGHT UNIVERSAL
1009660 Straight 190 -
1009660J J 190 -
1009661 Straight 300 -
1009661J J 300 -
HT BALANCE
MIDDLEWEIGHT UNIVERSAL II
1009664 Straight 190 -
1009664J J 190 -
1009665 Straight 300 -
1009665J J 300 -
HT FLOPPY II 22339H Straight 190 Hydrophilic coated tip,
2 cm radiopaque tip
22339M Straight 190 Hydrophobic coated tip,
2 cm radiopaque tip
22339MJ J 190 Hydrophobic coated tip,
2 cm radiopaque tip
22339M-903 Straight 190 Hydrophobic coated tip,
30 cm radiopaque tip
22359M Straight 300 Hydrophobic coated tip,
2 cm radiopaque tip
22359MJ J 300 Hydrophobic coated tip,
2 cm radiopaque tip
HT FLOPPY II ES 22299H Straight 190 Hydrophilic coated tip,
2 cm radiopaque tip
22299M Straight 190 Hydrophobic coated tip,
2 cm radiopaque tip
22299M-901 Straight 190 Hydrophobic coated tip,
30 cm radiopaque tip
22359M-901 Straight 300 Hydrophobic coated tip,
2 cm radiopaque tip

SPECIALTY

Wire Name Part Number Tip Shape Wire Length (cm) Additional Detail
HT ALL STAR 1001740 Straight 190 -
1001740J J 190 -
1001741 Straight 300 -
1001741J J 300 -
HT BALANCE HEAVYWEIGHT 1000462H Straight 190 -
1000462HJ J 190 -
1000463H Straight 300 -
1000463HJ J 300 -
HT CROSS-IT 100XT 1003309H Straight 190 -
1003309HJ J 190 -
1003310H Straight 300 -
1003310HJ J 300 -
HT EXTRA S’PORT 22225M Straight 190 -
22225MJ J 190 -
22235M Straight 300 -
22235MJ J 300 -
HT IRON MAN 1001309 Straight 190 -
1001309J J 190 -
1001311 Straight 300 -
1001311J J 300 -
HT PILOT 50 1010480-H Straight 190 -
1010480-HJ J 190 -
1010483-H Straight 300 -
1010483-HJ J 300 -
HT PILOT 150 1010481-H Straight 190 -
1010481-HJ J 190 -
1010484-H Straight 300 -
1010484-HJ J 300 -
HT PILOT 200 1010482-H Straight 190 -
1010482-HJ J 190 -
1010485-H Straight 300 -
1010485-HJ J 300 -
HT PROGRESS 40 1011836 Straight 190 -
1011837 Straight 300 -
HT PROGRESS 80 1011838 Straight 190 -
1011839 Straight 300 -
HT PROGRESS 120 1011844 Straight 190 -
1011845 Straight 300 -
HT PROGRESS 140T 1011840 Straight 190 -
1011841 Straight 300 -
HT PROGRESS 200T 1011842 Straight 190 -
1011843 Straight 300 -
HT WHISPER ES 1011834H Straight 190 -
1011834HJ J 190 -
1011835H Straight 300 -
1011835HJ J 300 -
HT WHISPER LS 1005351H Straight 190 -
1005351HJ J 190 -
1005353H Straight 300 -
1005353HJ J 300 -
HT WHISPER MS 1005357H Straight 190 -
1005357HJ J 190 -
1005359H Straight 300 -
1005359HJ J 300 -
HT WIGGLE 22299M-W2 Straight 190 -
22359M-W2 Straight 300 -
       

INDICATIONS AND IMPORTANT SAFETY INFORMATION

rx-only-logo HI-TORQUE Guide Wires

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 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.

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 with 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 carries 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 in 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.

rx-only-logo HI-TORQUE Guide Wires for PTCA, PTA, and Stents

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 with 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 carries 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 in a metal cannula or sharp-edged object.

rx-only-logo HI-TORQUE Guide Wires for PTCA, PTA, and Stents

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.
  • 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 with 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 carries 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 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 in 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.

rx-only-logo HI-TORQUE ADVANCE Guide Wires

INDICATIONS FOR USE

The HI-TORQUE ADVANCE Guide Wires are intended to facilitate the placement of interventional percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.

CONTRAINDICATIONS

The HI-TORQUE ADVANCE Guide Wires are not intended for use in the cerebral vasculature.

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.

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 with 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 carries 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.

Avoid abrasion of the hydrophilic coating.

Do not withdraw or manipulate the hydrophilic-coated wire in 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.

rx-only-logo HI-TORQUE PROGRESS, HI-TORQUE PILOT Guide Wires for PTCA, PTA, Stents, CTO

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 PROGRESS family only: The 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.

OBSERVED ADVERSE EVENTS

During the EXPERT CTO trial, for the guide wire related objective of the study, In-hospital MACE (per ARC MI definition) occurred in 10.87% (15/138) of the subjects, with 0.72% (1/138) experiencing clinically-driven target lesion revascularization (TLR), 10.87% (15/138) experiencing MI, and no in-hospital death. In-hospital MACE (per protocol MI definition) occurred in 2.17% (3/138) of the subjects, with 0.72% (1/138) experiencing clinically-driven TLR, 1.45% (2/138) experiencing MI, and no in-hospital death.

rx-only-logo HI-TORQUE Guide Wires for PTCA, PTA, and Stents

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 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.

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 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.

rx-only-logo HI-TORQUE TURNTRAC Guide Wire

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.

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

 

rx-only-logo HI-TORQUE VERSATURN Guide Wire

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 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.

rx-only-logo HI-TORQUE WIGGLE Guide Wire

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.

AP2944071-WBU Rev. A

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