TAKE COMMAND OF THE CASE
- Hybrid design technology provides the best of both nitinol and stainless steel
- Durability. Period.
- 0.018” wires designed for access and cross above and below the knee.
Test(s) performed by and data on file at Abbott.
For outstanding vessel preparation and pre-dilatation for Supera. Learn More
Clinically proven for the SFA. Again and again.1 Learn More
1. Garcia L, et al. SUPERB final 3-year outcomes using interwoven nitinol biomimetic Supera stent. Circ Cardiovasc Interv. 2017;89:1259-1267. doi: 10.1002/ccd.27058.
Palena LM. SUPERSUB Trial: 1-year outcomes of SUPERa SUBintimal stenting in CLI patients. LINC 2016.
Werner M, et al. Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results for the Leipzig SUPERA 500 registry. EuroIntervention. 2014:10:861-868.
Brescia AA, et al. Stenting of femoropopliteal lesions using interwoven nitinol stents, J Vasc Surg. 2015;61:1472-1478. doi: 10.1016/j.jvs.2015.01.030.
Garcia L, et al. Wire-interwoven Nitinol stent outcome in the superficial femoral and proximal popliteal arteries twelve-month results of the SUPERB Trial. Circ Cardiovasc Interv. 2015;8:e000937. doi: 10.1161/CIRCINTERVENTIONS.113.000937.
|Product Description||Wire diameter||Nitinol length||Tip Load||Tip Shape||Wire length||Part Number|
|HT Command 18 ST||0.018”||10 cm||4 g||Straight, Shapeable||210 cm||1013730|
|HT Command 18 ST||0.018”||10 cm||4 g||Straight, Shapeable||300 cm||1013731|
|HT Command 18 LT||0.018”||25 cm||4 g||Straight, Shapeable||210 cm||1013752|
|HT Command 18 LT||0.018”||25 cm||4 g||Straight, Shapeable||300 cm||1013753|
Hi-Torque Command 18 is packaged with a torque device and guide wire introducer that can be used for tip shaping
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 infrapopliteal 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 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.
• 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.
• 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.
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:
• Abrupt closure
• Allergic reaction (contrast medium, drug, guide wire material)
• Amputation or limb loss
• Aneurysm or pseudoaneurysm in vessel or at vascular access site
• Angina or coronary ischemia, arrhythmia (including premature beats, bradycardia, atrial or ventricular tachycardia, atrial or ventricular fibrillation)
• Arteriovenous fistula
• Bleeding complications requiring transfusion or surgical intervention
• Critical limb ischemia
• Detachment of a system component
• Embolization (air, tissue, plaque, thrombotic material, device)
• Emergent surgery
• Hematoma or hemorrhagic event, with or without surgical repair
• Hypotension / hypertension
• Ischemia or infarction not covered under other AEs
• Myocardial infarction
• Pain (leg, foot, back and / or insertion site)
• Perforation or rupture
• Peripheral nerve injury
• Pulmonary embolism
• Renal failure or insufficiency secondary to contrast medium (with or without treatment including dialysis)
• Tissue injury
• Transient ischemic attack
• Venous thromboembolism
• Vessel dissection
• Vessel spasm or recoil
• Worsening claudication
AP2946394-WBU Rev. A
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