Peripheral Artery Disease (PAD) is a significant global health burden, affecting over 236 million people worldwide1 and presents in 15-20% of people > 70 years of age.2 As a global leader in peripheral intervention, Abbott offers innovative products to treat the full spectrum of PAD and chronic limb threatening ischemia (CLTI).
Every lower limb case is unique, and no two lesions are the same. That is why we focus on providing the therapies, tools, and specialized knowledge that enable you to tailor your approach and optimize long-term, durable outcomes.
Our comprehensive portfolio offers individualized solutions for every step in lower limb care from ACCESS to CLOSE.
Gain access with the right guide wires.
Clear obstacles with peripheral dilatation catheters, embolic protection, and orbital atherectomy.
Treat confidently with DRS, DCB, and nitinol stents.
Manage hemostasis efficiently.
Beyond the treatment, make sure your referring physicians are fully aware of PAD and CLTI and how they can help with early diagnosis and timely treatment. For information specifically for the physician, visit our Clear Program webpage. Access a full range of helpful tools and insights. And for your patients, refer them to the PAD-info.com link to support the work you do, so they can learn about PAD symptoms and access an educational brochure.
Physicians' information on how to help their patients understand PAD
Patients' information about Peripheral Artery Disease
Request an Abbott Sales Rep
References
MAT-2500698 v1.0
This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. 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.
Not intended for use in the coronary or cerebral vasculature.
This device is not designed for use with atherectomy devices.
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.
Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.
Do Not:
• Push, auger, withdraw, or torque a guide wire that meets excessive 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.
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.
Potential Adverse Events associated with use of this device may include the following but are not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.
MAT-2307869 v1.0
INDICATIONS FOR USE
This Hi-Torque™ Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries.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 coronary or cerebral vasculature.
WARNINGS
This device is not designed for use with artherectomy 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:
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.
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 (AEs)
Potential Adverse Events associated with use of this device may include the following but are not limited to:
MAT-2111768 v2.0
The Hi-Torque™ Steerable Guide Wire is intended for use in angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. The wire can be torqued to facilitate navigation through tortuous vessels.
The Hi-Torque™ Steerable Guide Wire is not intended for use in the coronary or neurovasculature.
The Hi-Torque™ Steerable Guide Wire is not intended for use in the coronary or neurovasculature.
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. Wipe the wire before all exchanges.
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 from the device. Use the radiopaque marker of the interventional device to confirm position.
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.
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.
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-2306607 v1.0
INDICATIONS FOR USE
The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are indicated to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures.
The guide wires 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
The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are not intended for use in the coronary or cerebral vasculature.
WARNINGS
This device is not designed for use with atherectomy devices. The safety and effectiveness of the use of the Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire with atherectomy devices are not established.
Use the guide wire prior to the “Use-by date” specified on the package. This device is designed and intended for ONE TIME USE ONLY. Do not resterilize and / or reuse. The safety and effectiveness of this device have not been established after being reprocessed for multiple uses.
Use extreme caution and careful judgement in patients for whom anticoagulation is not indicated.
If contrast agents are used, use extreme caution in patients who have had a severe reaction to contrast agents and who cannot be adequately premedicated.
Persons with known history of allergies to any of the components of this device listed below may develop an allergic reaction to this guide wire: stainless steel, nitinol (nickel-titanium alloy), platinum-nickel alloy, polytetrafluoroethylene (PTFE) coating, silicone-based hydrophobic coating, tungsten polymer sleeve, urethane, polyvinylpyrrolidone (PVP) coating, tin-silver alloy, gold-tin alloy, and epoxy adhesive. Prior to its use on the patient, the patient should be counseled on the materials contained in the device, and a thorough history of allergies must be discussed.
This device has a hydrophilic coating at the distal end of the device and hydrophobic coatings at the proximal end of the device that increases the lubricity of the guide wire surface for lengths as specified in the table below:
| Product | Type of Coating and Coating Length at the Distal End | Type of Coating and Coating Length at the Proximal End | Hydrophobic PTFE Coating Location (Proximal) |
|---|---|---|---|
| Hi-Torque Command 14 ST, 210 cm | PVP Coating (Hydrophilic coating), 10 cm | Microglide Coating (Hydrophobic coating), 182 cm | Under Microglide Coating, 184 cm |
| Hi-Torque Command 14 ST, 300 cm | PVP Coating (Hydrophilic coating), 10 cm | Microglide Coating (Hydrophobic coating), 264.5 cm | Under Microglide Coating, 276 cm |
| Hi-Torque Command 14 MT, 210 cm | PVP Coating (Hydrophilic coating), 25 cm | Microglide Coating (Hydrophobic coating), 167 cm | Under Microglide Coating, 169 cm |
| Hi-Torque Command 14 MT, 300 cm | PVP Coating (Hydrophilic coating), 25 cm | Microglide Coating (Hydrophobic coating), 249.5 cm | Under Microglide Coating, 261 cm |
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 result in serious adverse events.
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
The Hi-Torque Command™ 14 ST and MT Guide Wire Family has distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessels, 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.
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.
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.
Avoid abrasion of the coating. Do not withdraw or manipulate the coated guide 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.
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.
When wet, a hydrophilic coating increases the lubricity of the guide wire surface.
The coating swells when exposed to aqueous media; however, this does not have any impact on 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 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.
The safety and effectiveness of the Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire have not been established in the pediatric population.
ADVERSE EVENTS
Potential adverse events associated with use of this device may include the following but not limited to:
MAT-2407512 v1.0
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.
Not intended for use in the cerebral vasculature or 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:
For Winn™ family only: The Winn™ family of guide wires have distal ends of varying stiffness. Operate these guide wires carefully so as not to 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.
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.
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-2306605 v1.0
Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.
Hi-Torque wires are not intended for use in the coronary and cerebral vasculature or in patients judged not acceptable for percutaneous intervention.
A guide wire is a delicate instrument and must not be advanced, withdrawn, or torqued if resistance is met. Guide wire manipulations must always be observed under fluoroscopy.
The Hi-Torque 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.
If the guide wire is removed and is to be re- inserted, it must be inspected for signs of damage (weakened or kinked segments) prior to re-introduction. Do not re- introduce if guide wire is weakened or kinked.
Do Not:
Do:
MAT-2307413 v1.0
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).
Hi-Torque Guide Wires are not intended for use in the cerebral vasculature.
This device is designed and intended for ONE-TIME USE ONLY. DO NOT RESTERILIZE AND / OR REUSE.
Observe 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. In addition, during catheter manipulations, ensure that the distal guide wire tip is visible.
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. If guide wire tip prolapse is observed or used for positioning, do not allow the tip to remain in a prolapsed condition; otherwise, damage to the guide wire may occur. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.
If the guide 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 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.
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.
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-2306606 v1.0
Hi-Torque Supra Core™ 35 Guide Wires are intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures.
Refer to the device label for any additional product specific indications which may apply.
The Hi-Torque Supra Core™ 35 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.
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. Wipe the wire before all exchanges.
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.
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.
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.
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-2306103 v1.0
The device is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 to 4.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents up to 40 mm and self-expanding stents up to 80 mm in the vessels listed above.
The safety of using additional balloon diameters and/or lengths to post dilate stents has not been established.
The following complications may occur as a result of PTA, but may not be limited to:
MAT-2114592 v2.0
The Armada™ 14 XT PTA Catheter is indicated to dilate stenosis in femoral, popliteal, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 mm to 5.0 mm balloon diameters are also indicated for post-dilatation of stents in the peripheral vasculature.
The Armada™ 14 XT PTA Catheter is contraindicated for:
This device is intended for one time use only. DO NOT resterilize and / or reuse it, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.
Any use for procedures other than those indicated in these instructions is not recommended.
Precautions to prevent or reduce clotting should be taken when any catheter is used.
The size of the inflated balloon should be selected not to exceed the diameter of the artery immediately distal, or proximal, to the stenosis.
Balloon pressure should not exceed the rated burst pressure (RBP). The RBP is based on results of in vitro testing. At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their RBP. Use of a pressure-monitoring device is recommended to prevent over- pressurization.
To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.
Do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. Instead, prepare a new catheter.
Do not torque the catheter more than one (1) full turn.
If a distal protection device is used, follow the manufacturer’s instruction for use. Allow and maintain adequate distance between the Armada™ 14 XT PTA Catheter and the distal protection device to avoid engagement.
Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.
When the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of resistance before proceeding.
Treatment of moderately or heavily calcified lesions increases the risk of acute closure, vessel trauma, balloon burst, balloon entrapment, and associated complications. If resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.
In the event of catheter damage / separation, recovery of any portion should be performed based on physician determination of individual patient condition and appropriate retrieval protocol.
In cases of extreme vessel tortuosity, it may be necessary to reposition the catheter in a straight segment of the vessel in order to allow guide wire exchange. Do not continue to use a catheter if excessive resistance is felt during guide wire exchanges. Instead, prepare a new catheter.
This device should only be used by physicians who are experienced and have a thorough understanding of the clinical and technical aspects of PTA.
Note the “Use by” date specified on the package.
Inspect all product prior to use. Do not use if the package is open or damaged.
Prior to angioplasty, the PTA catheter should be examined to verify functionality and ensure that its size is suitable for the specific procedure for which is to be used.
Precautions to prevent or reduce clotting should be taken when any catheter is used.
Flush or rinse all products entering the vascular system with sterile heparinized normal saline or a similar solution via the guide wire access port prior to use. Consider the use of systemic heparinization.
Never attempt to move the guide wire when the balloon is inflated.
The minimal acceptable sheath / guiding catheter French size is printed on the package label. Do not attempt to pass the Armada™ 14 XT PTA Catheter through a smaller sized sheath / guiding catheter than indicated on the label.
If the surface of the Armada™ 14 XT PTA Catheter becomes dry, wetting with heparinized normal saline will reactivate the coating.
Do not reinsert the Armada™ 14 XT PTA Catheter into the coil dispenser after procedural use.
Bench testing was conducted with 0.014" (0.36 mm) constant diameter guide wires to establish guide wire compatibility. If another type of guide wire is selected with a different dimensional profile, the compatibility (e.g., wire resistance) should be considered prior to use.
The safety and effectiveness of this PTA balloon catheter for the treatment of in-stent restenosis (ISR) have not been established.
Possible adverse effects include, but are not limited to, the following:
MAT-2114593 v2.0
The Armada™ 18 is indicated to dilate stenosis in femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the device is also indicated for post-dilatation of balloon expandable and self-expanding stents.
The following complications may occur as a result of PTA, but may not be limited to:
MAT-2114595 v2.0
The device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
This device is also indicated for stent post-dilatation in the peripheral vasculature.
The following complications may occur as a result of PTA, but may not be limited to:
MAT-2114594 v2.0
INDICATIONS
The JADE‡ PTA Balloon Dilation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.
CONTRAINDICATIONS
The use of the JADE‡ PTA Balloon Dilatation Catheter is contraindicated:
WARNINGS
When using this type of device, the following warnings should be observed:
PRECAUTIONS
ADVERSE EFFECTS
Adverse effects due to the use of this product include, but are not limited to, the following:
MAT-2400998 v2.0
The Emboshield NAV6™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
The Emboshield NAV6™ Embolic Protection System is contraindicated for use in
Use of the device should be restricted to physicians trained to the specifics of the device and to the Instructions for Use. Operators must be knowledgeable of the current medical literature and familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid and lower extremity interventional procedures.
Refer to instructions supplied with all interventional devices to be used with the Emboshield NAV6™ Embolic Protection System for their intended uses, contraindications, and potential complications. The Emboshield NAV6™ System is supplied sterile. Do not use if the package has been opened or is damaged. Carefully inspect the system components prior to use to verify that they have not been damaged and that the size, shape and condition are suitable for the procedure for which they are to be used. A device or access device that is kinked or damaged in any way should not be used. Safety and effectiveness of this device as an embolic protection system has not been established in the coronary or cerebral vasculature. The safety and efficacy of the Emboshield NAV6™ Embolic Protection System has not been demonstrated with carotid stent systems other than the Xact™ or Acculink™ Carotid Stent Systems. The safety and efficacy of the Emboshield NAV6™ Embolic Protection System has not been demonstrated with atherectomy devices other than Turbo-Elite‡ Laser Atherectomy Catheter, Jetstream‡ Single Cutter (SC) Atherectomy Catheter, Jetstream‡ eXpandable Cutter (XC) Atherectomy Catheter and TurboHawk‡ Peripheral Plaque Excision System. The Emboshield NAV6™ device can only be used with the BareWire™ Filter Delivery Wire. Use of the device with any guide wire other than the BareWire™ Filter Delivery Wire will lead to loss of the Filtration Element during the procedure or an inability to retrieve the Filtration Element. To reduce the potential for the liberation of emboli during lesion crossing, the device should be carefully manipulated and not advanced against resistance. If the Filtration Element moves into the stented vessel segment prior to retrieval, DO NOT RETRIEVE. Use the Retrieval Catheter to gently maneuver the Filtration Element distally until it is situated in an unstented portion of vessel. Retrieval should then proceed. Maintain proper guiding catheter / sheath support throughout the procedure. Ensure that there is enough distance between the proximal tip of the Filtration Element and the most distal tip of any interventional device to be introduced over the Filter Delivery Wire to avoid engagement. The tip of a balloon catheter or a stent delivery system or an atherectomy device should not contact the Filtration Element. Failure to maintain adequate distance could result in inadvertent Filtration Element movement and Stent Delivery System tip / Filtration Element entanglement and / or Filtration Element /Stent entanglement if guide catheter or sheath prolapse occurs. Precautions to prevent or reduce clotting should be taken when any interventional device is used. Flush or rinse all devices entering the vascular system with heparinized normal saline or alternative anticoagulant, prior to use. The Emboshield NAV6™ Embolic Protection System must be used with a guiding catheter or introducer sheath to maintain adequate support for the BareWire™ Filter Delivery Wire throughout the procedure. Venous access should be available during carotid stenting in order to manage bradycardia and / or hypotension by either pharmaceutical intervention or place of a temporary pacemaker, if needed. Removal of the BareWire™ Filter Delivery Wire with the Emboshield NAV6™ Filtration Element through any interventional devices other than the Emboshield NAV6™ RX Retrieval Catheter has not been tested. The minimum expanded stent internal diameter required for retrieval of a large embolic load is 2.5 mm. As reported in the literature, the following adverse events are potentially associated with carotid stents and embolic protection systems: Any adverse event occurring involving the Emboshield NAV6™ Embolic Protection System should be reported immediately to Abbott Vascular, Customer Service: 1-800 227-9902.
Precautions
Potential Adverse Events
MAT-2208561 v2.0
Applies to Diamondback 360™ Peripheral Orbital Atherectomy System only: Including the Orbital Atherectomy Device (OAD) with GlideAssist™, Saline Pump, Viperwire Advance™ Peripheral Guide Wire, and Viperwire Advance™ with Flex Tip Peripheral Guide Wire
Applies to Diamondback 360™ Peripheral Orbital Atherectomy System – Exchangeable Series only: Including the Orbital Atherectomy Device (OAD), Handle, Orbital Atherectomy Cartridge, Saline Pump, Viperwire Advance™ Peripheral Guide Wire, and Viperwire Advance™ with Flex Tip Peripheral Guide Wire
INDICATIONS
The Diamondback 360™ Peripheral Orbital Atherectomy System/Diamondback 360™ Peripheral Orbital Atherectomy System – Exchangeable Series (OAS) is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS Solid, Classic and Micro Crowns support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.*
*The 2.00 Max Crown has not been tested to support removal of stenotic material from artificial dialysis fistulae (AV shunt).
CONTRAINDICATIONS
Use of the OAS is contraindicated in the following situations:
WARNINGS
PRECAUTIONS
Applies to Diamondback 360™ Peripheral OAS – Exchangeable Series only:
POTENTIAL ADVERSE EVENTS
Potential adverse events that may occur and/or require intervention include, but are not limited to:
Diamondback 360™ Peripheral OAS/Diamondback 360™ Peripheral OAS– Exchangeable Series are manufactured and distributed by Cardiovascular Systems, Inc. (CSI). CSI is a subsidiary of the Abbott Group of Companies.
MAT-2303958 v1.0
The Esprit™ BTK Everolimus Eluting Resorbable Scaffold System is indicated for improving luminal diameter in infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI) and total scaffolding length up to 170 mm with a reference vessel diameter of ≥ 2.5 mm and ≤ 4.00 mm.
The Esprit™ BTK Everolimus Eluting Resorbable Scaffold System is contraindicated for use in:
Potential adverse events include, but are not limited to:
Allergic reaction or hypersensitivity to contrast agent, anesthesia, scaffold materials (poly[L-lactide] [PLLA], poly[D, L-lactide] [PDLLA], platinum, or everolimus), and drug reactions to anticoagulation or antiplatelet drugs
The risks described below include the anticipated adverse events referenced in the contraindications, warnings, and precautions sections of the everolimus labels / SmPCs and / or observed at incidences ≥ 10% in clinical trials with oral everolimus for different indications. Refer to the drug SmPCs and labels for more detailed information and less frequent adverse events.
There may be other potential adverse events that are unforeseen at this time.
MAT-2403616 v1.0
The SurVeil‡ DCB is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (≤ 180 mm in length) in femoral and popliteal arteries having reference vessel diameters of 4 mm to 7 mm.
The SurVeil‡ DCB is contraindicated for use in:
DO NOT REUSE and/or RESTERILIZE the SurVeil‡ DCB. Reuse and/or resterilization may create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s). Contamination of the device may lead to injury, illness, or death of the patient. Reuse and/or resterilization may compromise integrity of the device, including the drug coating, or lead to device failure, which may result in patient injury, illness, or death. Surmodics is not responsible for any direct, incidental, or consequential damages resulting from reuse and/or resterilization.
Pre- and post-procedure medication regimen
It is strongly advised that the treating physician follow the Inter- Society Consensus (TASC II) Guidelines recommendations (or other applicable country guidelines) for antiplatelet therapy pre- and post-procedure
Potential adverse events, which may be associated with the use of a peripheral-dilatation balloon catheter procedure may include, but are not limited to, the following:
Potential adverse events that may be unique to the paclitaxel drug coating may include, but are not limited to:
SurVeil‡ is manufactured by Surmodics, Inc., distributed by Abbott Group of Companies
MAT-2213996 v1.0
Indications
The Supera™ Peripheral Stent System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and / or proximal popliteal artery with reference vessel diameters of 4.0 to 7.5 mm, and lesion lengths up to 140 mm.
Contraindications
The Supera™ Peripheral Stent System is contraindicated in:
Warnings
Precautions
The Supera™ Peripheral Stent System should only be used by physicians and medical personnel trained in vascular interventional techniques and trained on the use of this device.
Magnetic Resonance Imaging (MRI) Safety Information
Nonclinical testing has demonstrated that the Supera™ stent, in single and in overlapped configurations up to 250 mm in length, is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
Under the scan conditions defined above, the Supera™ stent is expected to produce a maximum temperature rise of 7.6 °C after 15 minutes of continuous scanning.
In nonclinical testing, the image artifact caused by the device extends approximately 2 cm from the Supera™ stent when imaged with a gradient echo or spin echo sequence and a 3T MRI system.
Potential Adverse Events
Potential adverse events include, but are not limited to:
MAT-2103597 v3.0
Indications:
The Perclose™ ProStyle™ Suture-Mediated Closure and Repair System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access sites of patients who have undergone diagnostic or interventional catheterization procedures.
The Perclose™ ProStyle™ SMCR System is indicated for closing the common femoral vein in single or multiple access sites per limb.
The Perclose™ ProStyle™ SMCR System is used without or, if required, with adjunctive manual compression.
For access sites in the common femoral artery using 5F to 21F sheaths. For arterial sheath sizes greater than 8F, at least two devices and the pre-close technique are required.
For access sites in the common femoral vein using 5F to 24F sheaths. For venous sheath sizes greater than 14F, at least two devices and the pre-close technique are required.
Caution:
Federal law restricts this medical device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in diagnostic and / or interventional catheterization procedures and who has been trained by an authorized representative of Abbott.
Prior to use, the operator must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device.
During closure of access sites using a procedural sheath greater than 8F, it is recommended that a vascular surgeon or a surgeon with vascular training be available in case surgical conversion to control bleeding and to repair the vessel is needed.
Contraindications:
There are no known contraindications to the use of this device.
Warnings:
Do not use the Perclose™ ProStyle™ SMCR System if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.
DO NOT RESTERILIZE OR REUSE. The Perclose™ ProStyle™ SMCR System is intended for single use only.
Do not use the Perclose™ ProStyle™ SMCR System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.
Do not use the Perclose™ ProStyle™ SMCR System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and / or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site. Note: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral vessel.
Do not use the Perclose™ ProStyle™ SMCR System in arterial or venous access if the puncture is through the posterior wall or if there are multiple punctures in the same access site, since such punctures may result in a hematoma or retroperitoneal bleed.
Do not use the Perclose™ ProStyle™ SMCR System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, or the bifurcation of these vessels, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site. Note: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral vessel.
Precautions:
Potential Adverse Events:
Potential adverse events associated with use of vessel closure devices may include, but are not limited to, the following:
MAT-2100368 v4.0
Indications:
The Perclose ProGlide™ Suture-Mediated Closure System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedures.
The Perclose ProGlide™ SMC System is indicated for closing the common femoral vein in single or multiple access sites per limb.
The Perclose ProGlide™ SMC System is used without or, if required, with adjunctive manual compression.
For access sites in the common femoral artery using 5F to 21F sheaths. For arterial sheath sizes greater than 8F, at least two devices and the pre-close technique are required.
For access sites in the common femoral vein using 5F to 24F sheaths. For venous sheath sizes greater than 14F, at least two devices and the pre-close technique are required.
Caution:
Federal law restricts this medical device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in diagnostic and / or interventional catheterization procedures and who has been trained by an authorized representative of Abbott.
Prior to use, the operator must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device.
During closure of access sites using a procedural sheath greater than 8F, it is recommended that a vascular surgeon or a surgeon with vascular training be available in case surgical conversion to control bleeding and to repair the vessel is needed.
Contraindications:
There are no known contraindications to the use of this device.
Warnings:
Do not use the Perclose ProGlide™ SMC System if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.
DO NOT RESTERILIZE OR REUSE. The Perclose ProGlide™ SMC System is intended for single use only.
Do not use the Perclose ProGlide™ SMC System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.
Do not use the Perclose ProGlide™ SMC System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and / or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site. Note: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral vessel.
Do not use the Perclose ProGlide™ SMC System in arterial or venous access if the puncture is through the posterior wall or if there are multiple punctures in the same access site, since such punctures may result in a hematoma or retroperitoneal bleed.
Do not use the Perclose ProGlide™ SMC System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, or the bifurcation of these vessels, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site. Note: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral vessel.
Precautions:
Potential Adverse Events:
Potential adverse events associated with use of vessel closure devices may include, but are not limited to, the following:
MAT-2100358 v4.0
The StarClose SE™ Vascular Closure System is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis, ambulation, and dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5F or 6F procedural sheath.
The StarClose SE™ Vascular Closure System is indicated for use to allow patients who have undergone diagnostic endovascular catheterization procedures to ambulate and be eligible for discharge as soon as possible after device placement.
The StarClose SE™ Vascular Closure System is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation in patients who have undergone interventional endovascular catheterization procedures utilizing a 5F or 6F procedural sheath.
Federal law restricts this device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in diagnostic and therapeutic catheterization procedures and who has been trained by an authorized representative of Abbott Vascular.
Prior to use, the operators must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device.
The StarClose SE™ Vascular Closure System is contraindicated for use in patients with known hypersensitivity to nickel-titanium.
Do not use the StarClose SE™ Vascular Closure System if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.
DO NOT RESTERILIZE OR REUSE. The StarClose SE™ Vascular Closure System and accessories are intended for single use only.
Do not use the StarClose SE™ Vascular Closure System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.
Do not use the StarClose SE™ Vascular Closure System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and / or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site.
Do not use the StarClose SE™ Vascular Closure System if the puncture is through the posterior wall or if there are multiple punctures, since such punctures may result in a retroperitoneal hematoma.
Do not use the StarClose SE™ Vascular Closure System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site.
The StarClose Clip has been shown to be MR Conditional immediately following implantation. A patient with this implant can be scanned safely immediately after clip placement under the following conditions:
In non-clinical testing, the StarClose Clip produced a temperature rise of 0.5°C at maximum MR system-reported whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of MR scanning in a 3 Tesla MR system using a transmit/receive body coil.
The MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the StarClose Clip. Therefore, optimization of MR imaging parameters to compensate for the presence of this implant may be necessary.
Potential adverse events that could be associated with the use of this device include:
MAT-2114590 v3.0
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