Armada 18 Catheter
VASCULAR
hamburger

COVERING YOUR SFA & BTK NEEDS

Precision and effective applications for above and below-the-knee

EXTENDED LENGTHS AND SIZES

  • Longer balloon lengths allow for efficient dilatation of long below-the-knee lesions
  • Unique diameters provide accurate dilatation of lesions in the SFA
  • Catheter lengths of 90 cm and 150 cm
  • 4F and 5F compatibility

OUTSTANDING PERFORMANCE

  • Transitionless co-axial design for outstanding pushability and guide wire trackability
  • One-piece catheter construction results in a large contrast lumen that minimizes deflation time
  • JETCOAT™ hydrophobic coating for smooth tracking and lesion crossing

TIP DESIGN OPTIMIZES LESION ENTRY AND CROSS1

Armada 18 Catheter SFA Tip Entry Armada 18 Catheter BTK Tip Entry

ONE-PIECE CATHETER CONSTRUCTION

RESULTS IN A LARGE CONTRAST LUMEN

THAT MINIMIZES DEFLATION TIME1

Armada 18 Catheter Design

Armada 18 Deflation Time Chart

1Tests performed by and data on file at Abbott Vascular.

Armada 18 Size and Specs Armada 18 Radial Compliance
Armada 18 Ordering Information

PRODUCT INFO

Our online product catalogs provide the very latest information available, right at your fingertips. Download catalogs by product family in PDF format, or view the entire Abbott Vascular inventory in Excel. Product barcodes enable direct scanning for easy reordering.

Indications and Important Safety Information

rx-only-logo Armada® 18 PTA Catheter

INDICATIONS

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 ventricular tachycardia, atrial or ventricular fibrillation)
  • Bleedingcomplications 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.

Prior to use, reference the Instructions for Use provided inside the product carton (when available) or at eifu.abbottvascular.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

AP2942981-WBU Rev. A

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.


The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?

false
accessibility
© 2016 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

accessibility

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.


The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?