Peripheral Dilatation Catheters

Indications

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.

Contraindications

The Armada™ 14 XT PTA Catheter is contraindicated for:

• Inability to cross lesion with a guide wire

Warnings

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.

Precautions

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.

Adverse Events

Possible adverse effects include, but are not limited to, the following:

• Abrupt closure
• Access site hematoma
• Aneurysm
• Angina
• Arrhythmias
• Arteriovenous fistula
• Bleeding complications which may require transfusion
• Cerebral ischemia / transient ischemic attack (TIA)
• Death
• Embolism (air, tissue, thrombotic, systemic or device component)
• Fever/pyrogenic reaction
• Hypersensitivity or allergic reaction to contrast agents and drug reactions
• Hypertension / hypotension
• Infection
• Ischemia, including tissue ischemia, steal syndrome and necrosis
• Leg edema
• Myocardial ischemia or infarction
• Nausea and vomiting
• Neuropathies or nerve injury
• Occlusion
• Organ failure (single, multiple)
• Pain
• Palpitations
• Pseudoaneurysm
• Renal failure / insufficiency
• Restenosis
• Stroke / cerebrovascular accident (CVA)
• Vascular complications, including entry site, which may require vessel repair
• Vascular thrombosis
• Vessel injury, e.g. dissection, perforation
• Vessel spasm

Indications

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.

Contraindications

• Inability to cross lesion with a guide wire
• Use in the coronary arteries
  
  

Warnings / Precautions

• This device should only be used by physicians who are experienced and have a thorough understanding of the clinical and technical aspects of PTA.
• One-time use only – do not resterilize! This single use device cannot be reused on another patient, as it is not designed to perform as intended after the first usage. Changes in mechanical, physical, and / or chemical characteristics introduced under conditions of repeated use, cleaning, and/ or resterilization may compromise the integrity of the design and / or materials, leading to contamination due to narrow gaps and / or spaces and diminished safety and / or performance of the device. Absence of original labeling may lead to misuse and eliminate traceability.  Absence of original packaging may lead to device damage, loss of sterility, and risk of injury to patient and / or user.
• Do not use if inner package is damaged or opened.
• Employ aseptic techniques during removal from the package and during use.
• Any use for procedures other than those indicated in these instructions is not recommended.
• Use prior to the use by date.
• Carefully inspect the catheter prior to use to verify that it has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.
• Precautions to prevent or reduce blood clotting should be taken when any catheter is used.
• Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution via the guide wire access port prior to  use. Consider the use of systemic heparinization.
• When the system is introduced into the vascular system, it should be manipulated only under high quality fluoroscopy.
• The Armada™ 18 PTA Catheter must always be introduced, moved and or withdrawn over a guide wire (max. 0.018″).
• Never attempt to move the guide wire when the balloon is inflated.
• Never use air or any gaseous medium to inflate  the balloon.
• Do not advance the Armada™ 18 PTA Catheter against significant resistance. The cause of resistance should be determined via fluoroscopy and remedial action taken.
• The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the Armada™ 18 PTA Catheter through a smaller sized sheath introducer than indicated on the label.
• The size of the inflated balloon should be selected not to exceed the diameter of the artery immediately distal, or proximal, to the stenosis.
• Inflation in excess of the rated burst pressure may cause the balloon to rupture. Use of a pressure monitoring device is recommended.
• If a distal protection device is used, follow the manufacturer’s instruction for use. Allow and maintain adequate distance between the  Armada™ 18 PTA Catheter and the distal protection device to avoid engagement.
• Rated burst pressure and balloon fatigue testing of the Armada™ 18 PTA balloons within deployed stents has demonstrated that the Armada™ 18 can safely post-dilate balloon expandable and self-expanding stents.
• When post-dilating stents, use a balloon length that is appropriate for the deployed stent length.

Potential Complications

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

• Abrupt closure
• Allergic reaction (contrast medium, drug, or stent material)
• Aneurysm, pseudoaneurysm or arteriovenous fistula
• Angina or coronary ischemia
• Arrhythmias (including premature beats, bradycardia, atrial or ventricle tachycardia, atrial or ventricular fibrillation)
• Bleeding complications requiring transfusion or surgical intervention
• Death
• Detachment and / or implantation of a component of the system
• Embolization, arterial or other (air, tissue, plaque, thrombotic material, device)
• Emergent or urgent surgery
• Fever
• Hematoma or hemorrhagic event with or without surgical repair
• Hyperperfusion syndrome
• Hypotension or hypertension
• Infection
• Ischemia or infarction of tissue or organ not covered under other adverse events
• Myocardial infarction
• Pain (limb or catheter site)
• Peripheral nerve injury
• Pulmonary embolism
• Renal failure or insufficiency
• Restenosis of vessel
• Shock
• Stroke, cerebrovascular accident (CVA), or transient ischemic attack (TIA)
• Target limb loss (amputation of toe, foot, and / or leg)
• Vascular thrombosis or occlusion at puncture site, treatment site, or remote site
• Venous thromboembolism
• Vessel dissection, perforation, or rupture
• Vessel spasm or recoil
• Worsening claudication or rest pain

Indications

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.

Contraindications

• Inability to cross lesion with a guide wire
• Use in the coronary arteries
  
  

Warnings / Precautions

• This device should only be used by physicians who are experienced and have a thorough understanding of the clinical and technical aspects of PTA.
• One-time use only – do not resterilize! This single use device cannot be reused on another patient, as it is not designed to perform as intended after the first usage. Changes in mechanical, physical, and/or chemical characteristics introduced under conditions of repeated use, cleaning, and/or resterilization may compromise the integrity of the design and/or materials, leading to contamination due to narrow gaps and/or spaces and diminished safety and/or performance of the device. Absence of original labeling may lead to misuse and eliminate traceability. Absence of original packaging may lead to device damage, loss of sterility, and risk of injury to patient and/or user.
• Do not use if inner package is damaged or opened.
• Employ aseptic techniques during removal from the package and during use.
• Any use for procedures other than those indicated in these instructions is not recommended.
• Use prior to the use by date.
• Carefully inspect the catheter prior to use to verify that it has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.
• Precautions to prevent or reduce blood clotting should be taken when any catheter is used.
• Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution via the guide wire access port prior to use.
• Consider the use of systemic heparinization.
• When the system is introduced into the vascular system, it should be manipulated only under high quality fluoroscopy.
• The Armada™ 35 / Armada™ 35 LL PTA Catheter must always be introduced, moved and or withdrawn over a guide wire (max. 0.035”).
• Never attempt to move the guide wire when the balloon is inflated.
• Never use air or any gaseous medium to inflate the balloon.
• Do not advance the Armada™ 35 / Armada™ 35 LL PTA Catheter against significant resistance. The cause of resistance should be determined via fluoroscopy and remedial action taken.
• The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the Armada™ 35 / Armada™ 35 LL PTA Catheter through a smaller sized sheath introducer than indicated on the label.
• The size of the inflated balloon should be selected not to exceed the diameter of the artery immediately distal, or proximal, to the stenosis.
• Inflation in excess of the rated burst pressure may cause the balloon to rupture. Use of a pressure monitoring device is recommended.
• When post-dilating stents, use a balloon length that is appropriate for the deployed stent length.

Potential Complications

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

• Abrupt closure
• Allergic reaction (contrast medium, drug, or device material)
• Aneurysm or pseudoaneurysm in vessel, or at vascular access site
• Angina or coronary ischemia
• Arrhythmias (including premature beats, bradycardia, atrial or ventricular tachycardia, arterial or ventricular fibrillation)
• Arteriovenous fistula
• Bleeding complications requiring transfusion or surgical intervention
• Death
• Detachment of a system component or implantation in an unintended site
• Embolization (air, tissue, plaque, thrombotic material, device)
• Emergent surgery
• Fever
• Hematoma or hemorrhagic event, with or without surgical repair
• Hyperperfusion syndrome
• Hypotension or hypertension
• Infection
• Ischemia or infarction not covered under adverse events
• Myocardial infarction
• Pain (leg, foot, and / or insertion site)
• Peripheral nerve injury
• Pulmonary embolism
• Renal failure or insufficiency
• Restenosis
• Shock
• Stroke
• Target limb loss (amputation of toe, foot, and / or leg)
• Thrombosis or occlusion
• Transient ischemic attack
• Venous thrombosis
• Vessel dissection, perforation, or rupture
• Vessel spasm or recoil
• Worsening claudication or rest pain