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Catalogs for Download
 
Peripheral Dilatation Catheters

Agiltrac .018 Peripheral Dilatation Catheter

Indications & Important Safety Information ›› IFU (Full Version) ››
 

 

Overview

agiltrac 018Discover where it will take you.

The Agiltrac .018 Peripheral Dilatation Catheter is Abbott Vascular's second-generation .018" guide-wire-compatible balloon. The design combines low profile with high pressure, eliminating the need to choose between the two performance characteristics. The low profile of the Agiltrac .018 Peripheral Dilatation Catheter is designed to allow use of a downsized sheath or guiding catheter, enable smooth delivery through tortuous anatomy, and cross lesions.

Specifications & Ordering Info.

Technical Specifications

STOCK NUMBERBalloon Diameter (mm)Crossing Profile (in)Nominal Pressure (atm)Rated Burst Pressure (atm)Proximal/Distal Shaft Diameter (F)Minimum Sheath SizeMinimum Guiding Catheter [ID (in)]Maximum Guide Wire (in)
PrefixSuffix
Catheter LengthBalloon Length (mm)
80 cm135 cm
1009324 1009352 -20 4.0 0.044 8 14 4.1/3.5 5F 6F (.068≤) 0.018
1009326 1009354 -20 5.0 0.045 8 14 4.1/3.5 5F 6F (.068≤) 0.018
1009328 1009356 -20 6.0 0.047 8 14 4.1/3.5 5F 6F (.068≤) 0.018
1009330 1009358 -20 7.0 0.047 8 14 4.6/4.1 5F 6F (.068≤) 0.018
1009332 1009360 -20 8.0 0.047 8 14 4.6/4.1 5F 7F (.078≤) 0.018
1009333 1009361 -20 9.0 0.051 8 12 4.6/4.1 6F 8F (.088≤) 0.018
1009334 1009362 -20 10.0 0.06 8 12 4.6/4.1 6F 8F (.088≤) 0.018
1009324 1009352 -30, -40 4.0 0.044 8 14 4.1/3.5 5F 6F (.068≤) 0.018
1009326 1009354 -30, -40 5.0 0.045 8 14 4.1/3.5 5F 6F (.068≤) 0.018
1009328 1009356 -30, -40 6.0 0.047 8 14 4.1/3.5 5F 6F (.068≤) 0.018
1009330 1009358 -30, -40 7.0 0.047 8 14 4.6/4.1 5F 7F (.078≤) 0.018
1009332 1009360 -30, -40 8.0 0.047 8 14 4.6/4.1 5F 7F (.078≤) 0.018
1009333 1009361 -30, -40 9.0 0.051 8 12 4.6/4.1 6F 8F (.088≤) 0.018
1009334 1009362 -30, -40 10.0 0.06 8 12 4.6/4.1 6F 8F (.088≤) 0.018
1009336 1009364 -30, -40 12.0 0.06 6 8 4.6/4.1 7F 9F (.098≤) 0.018
1009324 1009352 -60 4.0 0.044 8 14 4.1/3.5 5F 7F (.078≤) 0.018
1009326 1009354 -60 5.0 0.045 8 14 4.1/3.5 5F 7F (.078≤) 0.018
1009328 1009356 -60 6.0 0.047 8 14 4.1/3.5 5F 7F (.078≤) 0.018
1009330 1009358 -60 7.0 0.047 8 14 4.6/4.1 5F 7F (.078≤) 0.018
1009332 1009360 -60 8.0 0.047 8 14 4.6/4.1 6F 8F (.088≤) 0.018
1009333 1009361 -60 9.0 0.051 8 12 4.6/4.1 6F 8F (.088≤) 0.018
1009334 1009362 -60 10.0 0.06 8 12 4.6/4.1 7F 9F (.098≤) 0.018

Compliance Chart

Balloon Diameter (mm)INFLATION PRESSURE (atm)
6789101112131415161718
4 3.84 3.92 4 4.08 4.15 4.23 4.3 4.38 4.45 4.52 4.59 4.65 4.72
5 4.85 4.93 5 5.07 5.13 5.19 5.25 5.31 5.36 5.4 5.45 5.49 5.53
6 5.79 5.9 6 6.1 6.2 6.29 6.38 6.47 6.56 6.64 6.72 6.8 6.87
7 6.71 6.86 7 7.14 7.28 7.43 7.56 7.7 7.84 7.98 8.11 8.24 8.38
8 7.64 7.82 8 8.18 8.36 8.54 8.72 8.9 9.08 9.26 9.43 9.61 9.79
9 8.56 8.78 9 9.23 9.46 9.69 9.93 10.18 10.43 10.68 10.94 - -
10 9.44 9.72 10 10.29 10.59 10.89 11.2 11.52 11.84 12.17 12.51 - -
12 12 12.43 12.87 13.31 13.76 14.21 14.67 - - - - - -

Tests performed by and data on file at Abbott Vascular.

AP2932931 Rev. B

 

Indications and Important Safety Information

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Agiltrac™ .018

Peripheral Dilatation Catheters

 

 

INDICATIONS

The AGILTRAC™ .018 Peripheral Dilatation Catheter is intended:

  • To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries).
  • For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

 

CONTRAINDICATIONS

None known for Percutaneous Transluminal Angioplasty (PTA).

 

WARNINGS

The AGILTRAC .018 Peripheral Dilatation Catheter is not intended for use in the coronary arteries.

 

This device is not recommended for stent delivery.

 

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.

 

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.

 

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 the resistance before proceeding.

 

Balloon pressure should not exceed the rated burst pressure (RBP). Refer to the product label for device specific information. 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.

 

Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.

 

Use the catheter prior to the "Use By" date specified on the package.

 

Do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked as this may result in the shaft breaking. Instead, prepare a new catheter.

 

PRECAUTIONS

A thorough understanding of the principles, clinical applications and risks associated with Percutaneous Transluminal Angioplasty (PTA) is necessary before using this product.

 

Any use for procedures other than those indicated in these instructions is not recommended.

 

This device is not recommended for use in lesions that may require inflation higher than those recommended for this catheter.

 

Do not use if package is open or damaged.

 

Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.

 

During the procedure, appropriate anti-coagulant therapy must be provided to the patient as needed. Anti-coagulant therapy should be continued for a period of time to be determined by the physician after the procedure.

 

ADVERSE EVENTS

Potential adverse events include but are not limited to:

  • Air embolization
  • Aneurysm
  • Arteriovenous fistula
  • Hematoma at puncture site
  • Thrombus
  • Vessel perforation or dissection

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