Armada 35 and 35 LL PTA Catheter
VASCULAR
hamburger
product photo

PROFILE AND PUSH

The profile you need with the push you want

CUSTOMIZED ENGINEERING

  • Outstanding pushability with balloon lengths from 20 mm to 250 mm
  • Balloon diameters from 3 mm to 14 mm   
  • Catheter lengths of 80 cm and 135 cm
  • Low profile tip to cross challenging lesions
  • High-rated burst pressures for frequently used sizes
  • 5-7F sheath compatibility

OUTSTANDING PERFORMANCE

  • Consistent pushability across all balloon sizes
  • Very fast deflation times, even with longer-sized balloons
  • Semicompliant balloons with high RBPs and excellent  rewrap

Greatest Pushability On the Market*


Armada 35 Lesion Crossing Profile

Lowest Crossing Profile On The Market*


Armada 35 Lesion Crossing Profile

Fast Deflation Times (Seconds)*


Armada 35 Fast Deflation Times

*Based on balloon crossing profile measurements, deflation measurements, and pushability performance bench tests among competitors (Admiral Xtreme™, Mustang™, EverCross™, Rival® and Dorado®) (n=5)

**Rival® balloon (6.0 x 150 mm), the longest commercially available for this balloon family.

Tests performed by, photos and data on file at Abbott Vascular.

Balloon Compliance

RBP Shown is for the 20mm length, nominal pressure and compliance data applies to all lengths within a diameter
Armada 35 Nominal/Rated Burst Pressures

Nominal/Rated Burst Pressure, Guide Compatibility


Armada 35 Nominal/Rated Burst Pressures

Armada 35 ordering information

Armada 35 LL 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™ 35 / Armada™ 35 LL Percutaneous Transluminal Angioplasty Catheter

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
  • Cerebral ischemia/transient ischemic attack (TIA)
  • 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 other 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

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.

AP2935518-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?