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 following complications may occur as a result of PTA, but may not be limited to:
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 overpressurization.
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 it 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: