Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE BALANCE™ | 28000-HC | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE BALANCE™ | 28000J-HC | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE BALANCE™ | 28001-HC | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE BALANCE™ | 28000 | 3 cm | Straight | Hydrophobic | 190 cm |
HI-TORQUE BALANCE™ | 28000J | 3 cm | J | Hydrophobic | 190 cm |
HI-TORQUE BALANCE™ | 28001 | 3 cm | Straight | Hydrophobic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE BALANCE MIDDLEWEIGHT™ | 1001780-HC | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE BALANCE MIDDLEWEIGHT™ | 1001780J-HC | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE BALANCE MIDDLEWEIGHT™ | 1001782-HC | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE BALANCE MIDDLEWEIGHT™ | 1001782J-HC | 3 cm | J | Hydrophilic | 300 cm |
HI-TORQUE BALANCE MIDDLEWEIGHT™ | 1001780 | 3 cm | Straight | Hydrophobic | 190 cm |
HI-TORQUE BALANCE MIDDLEWEIGHT™ | 1001780J | 3 cm | J | Hydrophobic | 190 cm |
HI-TORQUE BALANCE MIDDLEWEIGHT™ | 1001782 | 3 cm | Straight | Hydrophobic | 300 cm |
HI-TORQUE BALANCE MIDDLEWEIGHT™ | 1001782J | 3 cm | J | Hydrophobic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length | Marker |
---|---|---|---|---|---|---|
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ | 1009660 | 3 cm | Straight | Hydrophilic | 190 cm | Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ | 1009660J | 3 cm | J | Hydrophilic | 190 cm | Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ | 1009661 | 3 cm | Straight | Hydrophilic | 300 cm | Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ | 1009661J | 3 cm | J | Hydrophilic | 300 cm | Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ | 1009662 | 3 cm | Straight | Hydrophilic | 190 cm | No Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ | 1009662J | 3 cm | J | Hydrophilic | 190 cm | No Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ | 1009663 | 3 cm | Straight | Hydrophilic | 300 cm | No Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ | 1009663J | 3 cm | J | Hydrophilic | 300 cm | No Marker |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length | Marker |
---|---|---|---|---|---|---|
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ | 1009664 | 3 cm | Straight | Hydrophilic | 190 cm | Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ | 1009664J | 3 cm | J | Hydrophilic | 190 cm | Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ | 1009665 | 3 cm | Straight | Hydrophilic | 300 cm | Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ | 1009665J | 3 cm | J | Hydrophilic | 300 cm | Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ | 1009666 | 3 cm | Straight | Hydrophilic | 190 cm | No Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ | 1009666J | 3 cm | J | Hydrophilic | 190 cm | No Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ | 1009667 | 3 cm | Straight | Hydrophilic | 300 cm | No Marker |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ | 1009667J | 3 cm | J | Hydrophilic | 300 cm | No Marker |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE BALANCE HEAVYWEIGHT™ | 1000462H | 4.5 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE BALANCE HEAVYWEIGHT™ | 1000462HJ | 4.5 cm | J | Hydrophilic | 190 cm |
HI-TORQUE BALANCE HEAVYWEIGHT™ | 1000463H | 4.5 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE BALANCE HEAVYWEIGHT™ | 1000463HJ | 4.5 cm | J | Hydrophilic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE FLOPPY II™ | 22339H | 2 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE FLOPPY II™ | 22339M | 2 cm | Straight | Hydrophobic | 190 cm |
HI-TORQUE FLOPPY II™ | 22339MJ | 2 cm | J | Hydrophobic | 190 cm |
HI-TORQUE FLOPPY II™ | 22359M | 2 cm | Straight | Hydrophobic | 300 cm |
HI-TORQUE FLOPPY II™ | 22359MJ | 2 cm | J | Hydrophobic | 300 cm |
HI-TORQUE FLOPPY II™ | 22339M-903 | 30 cm | Straight | Hydrophobic | 190 cm |
HI-TORQUE FLOPPY II™ ES | 22299H | 2 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE FLOPPY II™ ES | 22299M | 2 cm | Straight | Hydrophobic | 190 cm |
HI-TORQUE FLOPPY II™ ES | 22299M-901 | 30 cm | Straight | Hydrophobic | 190 cm |
HI-TORQUE FLOPPY II™ ES | 22359M-901 | 2 cm | Straight | Hydrophobic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE POWERTURN™ | 1044594 | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE POWERTURN™ | 1044594J | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE POWERTURN™ | 1044595 | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE POWERTURN™ | 1044595J | 3 cm | J | Hydrophilic | 300 cm |
HI-TORQUE POWERTURN™ FLEX | 1044592 | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE POWERTURN™ FLEX | 1044592J | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE POWERTURN™ FLEX | 1044593 | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE POWERTURN™ FLEX | 1044593J | 3 cm | J | Hydrophilic | 300 cm |
HI-TORQUE POWERTURN™ ULTRA FLEX | 1044590 | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE POWERTURN™ ULTRA FLEX | 1044590J | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE POWERTURN™ ULTRA FLEX | 1044591 | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE POWERTURN™ ULTRA FLEX | 1044591J | 3 cm | J | Hydrophilic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length | Tip Coating |
---|---|---|---|---|---|---|
HI-TORQUE TURNTRAC™ | 1020013 | 3 cm | Straight | Hydrophilic | 190 cm | Coated tip |
HI-TORQUE TURNTRAC™ | 1020013J | 3 cm | J | Hydrophilic | 190 cm | Coated tip |
HI-TORQUE TURNTRAC™ | 1020015 | 3 cm | Straight | Hydrophilic | 300 cm | Coated tip |
HI-TORQUE TURNTRAC™ | 1020014 | 3 cm | Straight | Hydrophilic | 190 cm | Uncoated tip |
HI-TORQUE TURNTRAC™ | 1020014J | 3 cm | J | Hydrophilic | 190 cm | Uncoated tip |
HI-TORQUE TURNTRAC™ | 1020016 | 3 cm | Straight | Hydrophilic | 300 cm | Uncoated tip |
HI-TORQUE TURNTRAC™ FLEX | 1020009 | 3 cm | Straight | Hydrophilic | 190 cm | Coated tip |
HI-TORQUE TURNTRAC™ FLEX | 1020009J | 3 cm | J | Hydrophilic | 190 cm | Coated tip |
HI-TORQUE TURNTRAC™ FLEX | 1020011 | 3 cm | Straight | Hydrophilic | 300 cm | Coated tip |
HI-TORQUE TURNTRAC™ FLEX | 1020010 | 3 cm | Straight | Hydrophilic | 190 cm | Uncoated tip |
HI-TORQUE TURNTRAC™ FLEX | 1020010J | 3 cm | J | Hydrophilic | 190 cm | Uncoated tip |
HI-TORQUE TURNTRAC™ FLEX | 1020012 | 3 cm | Straight | Hydrophilic | 300 cm | Uncoated tip |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length | Tip Coating |
---|---|---|---|---|---|---|
HI-TORQUE VERSATURN™ | 1013317 | 3 cm | Straight | Hydrophilic | 190 cm | Coated tip |
HI-TORQUE VERSATURN™ | 1013317J | 3 cm | J | Hydrophilic | 190 cm | Coated tip |
HI-TORQUE VERSATURN™ | 1013319 | 3 cm | Straight | Hydrophilic | 190 cm | Uncoated tip |
HI-TORQUE VERSATURN™ | 1013319J | 3 cm | J | Hydrophilic | 190 cm | Uncoated tip |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE WHISPER™ MS | 1005357H | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE WHISPER™ MS | 1005357HJ | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE WHISPER™ MS | 1005359H | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE WHISPER™ MS | 1005359HJ | 3 cm | J | Hydrophilic | 300 cm |
HI-TORQUE WHISPER™ ES | 1011834H | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE WHISPER™ ES | 1011834HJ | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE WHISPER™ ES | 1011835H | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE WHISPER™ ES | 1011835HJ | 3 cm | J | Hydrophilic | 300 cm |
HI-TORQUE WHISPER™ LS | 1005351H | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE WHISPER™ LS | 1005351HJ | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE WHISPER™ LS | 1005353H | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE WHISPER™ LS | 1005353HJ | 3 cm | J | Hydrophilic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE EXTRA S'PORT™ | 22225M | 3 cm | Straight | Hydrophobic | 190 cm |
HI-TORQUE EXTRA S'PORT™ | 22225MJ | 3 cm | J | Hydrophobic | 190 cm |
HI-TORQUE EXTRA S'PORT™ | 22235M | 3 cm | Straight | Hydrophobic | 300 cm |
HI-TORQUE EXTRA S'PORT™ | 22235MJ | 3 cm | J | Hydrophobic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE ALL STAR™ | 1001740 | 3 cm | Straight | Hydrophobic | 190 cm |
HI-TORQUE ALL STAR™ | 1001740J | 3 cm | J | Hydrophobic | 190 cm |
HI-TORQUE ALL STAR™ | 1001741 | 3 cm | Straight | Hydrophobic | 300 cm |
HI-TORQUE ALL STAR™ | 1001741J | 3 cm | J | Hydrophobic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE IRONMAN™ | 1001309 | 3 cm | Straight | Hydrophobic | 190 cm |
HI-TORQUE IRONMAN™ | 1001309J | 3 cm | J | Hydrophobic | 190 cm |
HI-TORQUE IRONMAN™ | 1001311 | 3 cm | Straight | Hydrophobic | 300 cm |
HI-TORQUE IRONMAN™ | 1001311J | 3 cm | J | Hydrophobic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE CROSS-IT™ 100XT | 1003309H | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE CROSS-IT™ 100XT | 1003309HJ | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE CROSS-IT™ 100XT | 1003310H | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE CROSS-IT™ 100XT | 1003310HJ | 3 cm | J | Hydrophilic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE WIGGLE™ | 22299M-W2 | 2 cm | Straight | Hydrophobic | 190 cm |
HI-TORQUE WIGGLE™ | 22299M-W30 | 30 cm | Straight | Hydrophobic | 190 cm |
HI-TORQUE WIGGLE™ | 22359M-W2 | 2 cm | Straight | Hydrophobic | 300 cm |
HI-TORQUE WIGGLE™ | 22399M-W30 | 30 cm | Straight | Hydrophobic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE PILOT™ 50 | 1010480-H | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE PILOT™ 50 | 1010480-HJ | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE PILOT™ 50 | 1010483-H | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE PILOT™ 50 | 1010483-HJ | 3 cm | J | Hydrophilic | 300 cm |
HI-TORQUE PILOT™ 150 | 1010481-H | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE PILOT™ 150 | 1010481-HJ | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE PILOT™ 150 | 1010484-H | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE PILOT™ 150 | 1010484-HJ | 3 cm | J | Hydrophilic | 300 cm |
HI-TORQUE PILOT™ 200 | 1010482-H | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE PILOT™ 200 | 1010482-HJ | 3 cm | J | Hydrophilic | 190 cm |
HI-TORQUE PILOT™ 200 | 1010485-H | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE PILOT™ 200 | 1010485-HJ | 3 cm | J | Hydrophilic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE PROGRESS™ 140T | 1011840 | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE PROGRESS™ 140T | 1011841 | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE PROGRESS™ 200T | 1011842 | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE PROGRESS™ 200T | 1011843 | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE PROGRESS™ 40 | 1011836 | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE PROGRESS™ 40 | 1011837 | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE PROGRESS™ 80 | 1011838 | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE PROGRESS™ 80 | 1011839 | 3 cm | Straight | Hydrophilic | 300 cm |
HI-TORQUE PROGRESS™ 120 | 1011844 | 3 cm | Straight | Hydrophilic | 190 cm |
HI-TORQUE PROGRESS™ 120 | 1011845 | 3 cm | Straight | Hydrophilic | 300 cm |
Product | Part Number | Tip Radiopacity | Tip Shape | Distal Coatings | Wire Length |
---|---|---|---|---|---|
HI-TORQUE INFILTRAC™ | 1030001J | 3 cm | Micro-J | Hydrophilic | 190 cm |
HI-TORQUE INFILTRAC™ | 1030002J | 3 cm | Micro-J | Hydrophilic | 300 cm |
HI-TORQUE INFILTRAC™ PLUS | 1030003J | 3 cm | Micro-J | Hydrophilic | 190 cm |
HI-TORQUE INFILTRAC™ PLUS | 1030004J | 3 cm | Micro-J | Hydrophilic | 300 cm |
Data on file at Abbott.
MAT-2109383 v2.0
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:
Do:
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
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:
Do:
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
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:
Do:
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
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:
Do:
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:
MAT-2104727 v2.0
INDICATIONS FOR USE
This HI-TORQUE™ Guide Wire is intended to facilitate the delivery of catheter-based interventional devices during the following procedures:
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:
Do:
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
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:
Do:
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
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
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:
Do:
For the HI-TORQUE INFILTRAC™ Guide Wire family only: The HI-TORQUE INFILTRAC™ Guide Wire family have distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessel, observing the information in these instructions. The higher torque performance, stiffer distal ends, and/or higher advancement force may present higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels.
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:
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:
MAT-2109381 v2.0
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