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Peripheral Dilatation Catheters

Rx Viatrac 14 Plus Peripheral Dilatation Catheter

Indications & Important Safety Information ››
 

 

Overview

viatracRapid Exchange with Superb Control

The RX Viatrac 14 Plus Peripheral Dilatation Catheter features:

  • A .014" guide-wire-based delivery system, allowing treatment of stenosis in the peripheral arteries
  • Rapid exchange (RX) – Single-operator, simple balloon exchanges, shorter guide wires than OTW systems
  • Low profile – The system is 6F guide compatible across all sizes
Features
viatrac1view larger image

Low-Profile, Rapid-Exchange, .014" Delivery System

  • Designed for use with a small .014" guide wire profile for deliverability and crossability
  • Simple to use rapid exchange (RX) technology for efficient catheter exchanges and single operator control
viatrac2view larger image

High-Performance Balloon

  • Multi-compliant XCELON Balloon Material provides sizing flexibility
  • Up to 14 atm balloon designed for the treatment of stenosis in the peripheral arteries

viatrac3view larger image

viatrac4view larger image

Small Guiding Catheter and Sheath Compatibility

  • 6F guide for 4.0 to 6.0 mm and 7F guide for 6.5 to 7.0 mm
  • 4F sheath for 4.0 to 4.5 mm and 5F sheath for 5 - 7 mm
Specifications

Technical Specifications

STOCK NUMBERBalloon  Diameter   (mm)  Crossing   Profile   (in)Nominal   Pressure   (atm)  Rated  Burst  Pressure  (atm)Proximal/Distal   Shaft Diameter   (F)Minimum   Guiding   Cathether   [ID (in)]Minimum Sheath SizeMaximum   Guide  Wire  (in)
PrefixSuffix    
Catheter LengthBalloon    Length   (mm)  
80 cm135 cm
1008190   1008189   -15,  -20,  -30,  -40  4 0.036 8 14 3.3/3.3-2.9 6F (.067) 4F 0.014
1008192 1008191 -15,  -20,  -30,  -40  4.5 0.037 8 14 3.3/3.3-2.9 6F (.067) 4F 0.014
1008194 1008193 -15,  -20,  -30,  -40  5 0.038 8 14 3.3/3.3-2.9 6F (.067) 5F 0.014
1008196 1008195 -15,  -20,  -30,  -40  5.5 0.041 8 14 3.3/3.3 6F (.067) 5F 0.014
1008198 1008197 -15,  -20,  -30,  -40  6 0.043 8 14 3.6/3.3 6F (.067) 5F 0.014
1008200 1008199 -15,  -20,  -30,  -40  6.5 0.048 8 14 3.6/3.5 6F (.067) 5F 0.014
1008202 1008201 -15,  -20,  -30,  -40  7 0.049 8 14 3.6/3.5 6F (.067) 5F 0.014

 

Compliance Chart

Balloon Size (mm)INFLATION PRESSURE (atm)
10 11 12 13 14 15 16 17 18 
4 3.58  3.68  3.76  3.84  3.9  3.96  4.04  4.08  4.11  4.14  4.16  4.19  4.21  4.23  4.26  4.28 
4.5  3.88  4.11  4.2  4.36  4.43  4.5  4.56  4.61  4.66  4.7  4.75  4.79  4.83  4.87  4.92  4.97 
4.34  4.47  4.59  4.69  4.83  4.92  5.07  5.14  5.21  5.27  5.34  5.4  5.46  5.53  5.6  5.68 
5.5  4.94  5.06  5.17  5.26  5.35  5.43  5.5  5.57  5.63  5.68  5.74  5.79  5.84  5.9  5.95  6.01  6.08 
5.35  5.49  5.62  5.73  5.83  5.92  6.07  6.13  6.19  6.24  6.29  6.34  6.39  6.45  6.5  6.56 
6.5  5.76  5.93  6.08  6.21  6.32  6.42  6.5  6.57  6.63  6.68  6.73  6.77  6.81  6.85  6.88  6.92  6.97 
6.23  6.39  6.54  6.67  6.79  6.9  7.09  7.18  7.26  7.34  7.41  7.49  7.58  7.66  7.76  7.86 
Ordering Information
STOCK NUMBER
PrefixSuffix
Catheter LengthBalloon Length (mm)
80 cm135 cm
1008190 1008189 -15, -20, -30, -40
1008192 1008191 -15, -20, -30, -40
1008194 1008193 -15, -20, -30, -40
1008196 1008195 -15, -20, -30, -40
1008198 1008197 -15, -20, -30, -40
1008200 1008199 -15, -20, -30, -40
1008202 1008201 -15, -20, -30, -40

AP2937831-US Rev. B

 

Indications and Important Safety Information

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Viatrac™ 14 Plus

Peripheral Dilatation Catheters

 


Indications
The VIATRAC 14 PLUS Peripheral Dilatation Catheter is intended:

  • To dilate stenosis 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 VIATRAC 14 PLUS Peripheral Dilatation Catheter is not intended for use in the coronary arteries

 

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.

 

Shaft diameter differences should be taken into consideration when opening and tightening the hemostatic valve and upon withdrawal of the catheter.

 

It is important that the hemostatic valve (if used) is closed tightly enough to prevent blood leakage around the catheter shaft, yet not so tightly that it restricts the flow of contrast into and out of the balloon or restricts guide wire movement.

 

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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