Armada™ 18
Balloon Dilatation Catheter

Armada™ 18
Percutaneous Transluminal Angioplasty Catheter

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• The Armada™ 18 PTA Catheter must always be introduced, moved and or withdrawn over a guide wire (max. 0.018”).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
  
  

  Supera™ Peripheral Stent System

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:

• Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.
• Patients who cannot receive antiplatelet or anticoagulation therapy. Based on in vivo thrombogenicity testing, the device should not be used in patients who cannot be anticoagulated as there may be some thrombus formation in the absence of anticoagulation.

Warnings:

• This device is intended for single-use only. Do not reuse. Do not resterilize. Do not use if the package is opened or damaged.
• Use this device prior to the “Use By” date as specified on the device package label. Store in a dry, dark, cool place.
• DO NOT use if it is suspected that the sterility of the device has been compromised.
• Persons with known hypersensitivities to Nitinol and / or its components (e.g. nickel-titanium) may suffer an allergic reaction to this implant.
• Administer appropriate antiplatelet therapy pre- and post-procedure.
• Careful attention should be paid when sizing and deploying the stent to prevent stent elongation. In the SUPERB clinical study, stent elongation was associated with a decrease in patency at 12 months.

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.

• The long-term safety and effectiveness of the Supera™ Peripheral Stent System has not been established beyond three years.
• The safety and effectiveness of the Supera Peripheral Stent System has not been established in patients who:
  • are less than 18 years old
  • are pregnant or lactating
  • have in-stent restenosis of the target lesion
  • have known hypersensitivity to any component of the stent system (e.g., nickel)
  • cannot tolerate contrast media and cannot be pre-treated
  • have uncontrolled hypercoagulability and / or other coagulopathy
• This device is not designed for use with contrast media injection systems or power injection systems.
• The flexible design of the Supera stent may result in variation in the deployed stent length.

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:

• Static magnetic field of 1.5 or 3.0 Tesla
• Maximum spatial gradient magnetic field of 2,500 Gauss/cm (25 T/m)
• Maximum MR whole-body-averaged specific absorption rate (SAR) of
  • 2 W/kg for landmarks (i.e. center of RF coil) above the umbilicus
  • 1 W/kg for landmarks below the umbilicus and above the mid-thigh
  • 0.5 W/kg for landmarks below the mid-thigh

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:

• Abrupt closure
• Allergic reaction (contrast medium; drug; stent 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
• Death
• Detachment of a system component or implantation in an unintended site
• Embolization, arterial or other (e.g. air, tissue, plaque, thrombotic material, or stent)
• Emergent surgery
• Fever
• Hematoma or hemorrhagic event, with or without surgical repair
• Hyperperfusion syndrome
• Hypertension / Hypotension
• Infection
• Myocardial infarction
• Pain (leg, foot, and/or insertion site)
• Partial stent deployment
• Peripheral nerve injury
• Pulmonary embolism
• Renal failure or insufficiency
• Restenosis of vessel in stented segment
• Shock
• Stent malapposition or migration, which may require emergency surgery to remove stent
• Stent strut fracture
• Thrombosis or occlusion
• Stroke
• Transient ischemic attack
• Venous thromboembolism
• Vessel dissection, perforation or rupture
• Vessel spasm or recoil
• Worsening claudication or rest pain