Highlander™ 014 PTA Balloon Dilatation Catheter

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.

²  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