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Highlander™ Highlander™ 014 PTA Balloon Dilatation Catheter

Highlander™ 014 PTA Balloon Dilatation Catheter

2.5 mm x 20 mm Balloon, 150 cm long catheter

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Overview

The Highlander™ 014 PTA Balloon Dilatation Catheter is a fiber-based, non-compliant balloon that is designed to deliver highly precise diameters and lengths relative to labeled sizing, even at high pressures.

 

  • Highly Precise Sizing
    • In bench testing, the Highlander™ 014 PTA Balloon Dilatation Catheter provided more precise sizing relative to labeled diameter, on average, at both Nominal Pressure and Rated Burst Pressure (RBP) compared to select leading competitors. 1    

 

  • Highly Controlled Compliance
    • In bench testing, the Highlander™ 014 PTA Balloon Dilatation Catheter had significantly less outer diameter and longitudinal growth, on average, between Nominal Pressure and RBP compared to select leading competitors. 2

 

  • Unmatched Strength
    • The Highlander™ 014 PTA Balloon Dilatation Catheter has the largest working pressure range and highest RBP of any 0.014 or 0.018 PTA balloon. 3
    • First and only fiber-based non-compliant balloon available on an 0.014 guidewire platform. 3

 

  • Low Profile
    • The Highlander™ 014 PTA Balloon has 4F sheath compatibility across all sizes.
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References

1  Accuracy measurements based on variance in balloon outer diameter between Nominal Pressure (NP) and Rated Burst Pressure (RBP) compared to labeled diameter for 2 mm balloons. Balloon outer diameters are measured at center of the balloon at NP and at RBP.  Mean results reported in mm, as follows: Highlander™ 014 Balloon (NP: 1.97, RBP: 2.00); Armada™ 14 (NP: 1.88, RBP: 2.01); Coyote™ (NP: 1.82, RBP: 2.02); and Pacific Plus™ (NP: 2.04, RBP: 2.32). All balloons tested were 2x150 mm, besides Armada™ 14 which was 2x200 mm. N=5 for all balloons tested. Data on file. BD, Tempe, AZ. Bench data may not be indicative of actual clinical performance. Different test methods may yield different results.

 Outer diameter measurements taken from center of balloon at NP and RBP. Mean results reported for percentage outer diameter growth, as follows: Highlander™ 014 Balloon (2.37%); Jade™ 014 (4.73%); Armada™ 14 (7.49%); Nanocross™ (9.02%); and Coyote™ (14.93%). Length measurements taken from point of cone taper at proximal and distal ends of the balloon at NP and RBP. Mean results reported for percentage longitudinal growth, as follows: Highlander™ 014 Balloon (0.67%); Jade™ 014 (2.18%); Armada™ 14 (2.30%); Nanocross™ (2.58%); and Coyote™ (2.84%). All balloons tested were 4x150 mm, besides Armada™ 14 which was 4x200 mm. N=5 for all balloons tested. Bench test data on file. BD, Tempe, AZ. Bench test results may not necessarily be indicative of clinical performance. Different test methods may yield different results.

 

3  As of January 2023. US market only.  EVT Device Guide, PTA Balloons.  Competitive balloon material information obtained from product web pages and/or 510(k) summaries.

 Please consult product labels and instruction for use for indications, contraindications, hazards, warnings and precautions.

BD-81022

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Specification

GTIN - Each

00801741213397

1


Balloon Diameter

2.5 mm

Balloon Length

20 mm

Catheter Length

150 cm

Sheath Size

4F

Rated Burst Pressure (atm)

30

Nominal Pressure (atm)

6

GTIN

GTIN - Each 00801741213397 1

Product Basic Specification

Balloon Diameter 2.5 mm
Balloon Length 20 mm
Catheter Length 150 cm
Sheath Size 4F
Rated Burst Pressure (atm) 30
Nominal Pressure (atm) 6
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