IMPORTANT SAFETY INFORMATION

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 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.

 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.

 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.

 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.

 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.