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Pantera Lux

PACLITAXEL-RELEASING BALLOON

 

Indicated for in-stent restenosis, de novo lesions, small vessels and acute occlusions.1 Expand your universe of treatment options with this clinically proven solution. Using the highly biocompatible BTHC excipient, Pantera Lux effectively delivers a proven antiproliferative drug to the lesion site – without leaving an implant behind.

 KEY FACTS
  • Clinically proven solution in both in-stent restenotic and de novo lesions2,3
  • Advanced trackability to smoothly reach the lesion site
  • Highly biocompatible BTHC excipient for safe results

Product Details

 Clinically Proven Solution in Both In-Stent Restenotic and De Novo Lesions

Clinical outcomes from both the PEPPER and DELUX clinical studies with more than 1000 patients show high efficacy and safety for Pantera Lux in both in-stent restenotic and de novo lesions.

 Advanced Trackability to Smoothly Reach the Lesion Site
Pantera Lux is based on the Pantera semi-compliant balloon and provides advanced trackability to successfully reach and treat most cases in daily practice.


 Highly Biocompatible BTHC Excipient for Safe Results

Pantera Lux coating technology blends paclitaxel with BTHC, a rapidly metabolized, safe and biocompatible excipient4, thus improving bioavailability. Homogeneous balloon coating ensures proper treatment of drug to the entire region touched by the balloon inflation, minimizing geographic miss. Tissue retention: Following one application of the Pantera Lux, paclitaxel can be readily detected in the treated region beyond seven days in animal tissue.

Technical Data

Drug-Releasing Balloon
Catheter typeFast-exchange PTCA balloon catheter
Recommended guide catheter5F (min. I.D. 0.056”)
Lesion entry profile0.017”
Guide wire diameter0.014”
Usable catheter length140 cm
Balloon folding3-fold
Ballon markersTwo embedded platinum-iridium markers
Brachial shaft marker92 cm from tip
Femoral shaft marker102 cm from tip
Proximal shaft diameter2.0 F
Distal shaft diameter2.5 F (ø 2.0 – 3.5 mm), 2.6F (ø 4.0 mm)
Nominal Pressure (NP)7 atm
Rated Burst Pressure (RBP)13 atm (ø 2.0 – 3.5 mm); 12 atm (ø 4.0 mm)
Coating
DrugPaclitaxel
Drug dose3.0 μg/mm²
Delivery matrixPaclitaxel and Butyryl-tri-hexyl citrate (BTHC)
Coated areaCylindrical section of the balloon, exceeding the proximal and distal markers

Compliance Chart

Balloon Diameter x Length (mm)
Nominal Pressureatm577777
(NP)ø (mm)2.002.503.003.504.00
Rated Burst Pressureatm51313131312
(RBP)ø (mm)2.262.823.484.114.59