Pantera Lux

Afbeelding
Pantera Lux
Pantera Lux Paclitaxel-Releasing Balloon
Afbeelding
Pantera Lux
Pantera Lux Paclitaxel-Releasing Balloon
Afbeelding
Pantera Lux
Pantera Lux Paclitaxel-Releasing Balloon
Afbeelding
Pantera Lux
Pantera Lux Paclitaxel-Releasing Balloon

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.


        DELUX Registry

        • Prospective, multi-center international registry
        • Number of patients (n): 1,064

        ISAR-DESIRE 4 RCT

        • Prospective, randomized, active, controlled multi-center clinical trial to compare the anti-restenotic efficacy of scoring balloon (SCB) pre-dilation before drug-coated balloon (DCB) therapy versus standard balloon pre-dilation (Plain Old Balloon Angioplasty, POBA) before DCB therapy in patients with limus-eluting stent (LES) restenosis. Baseline characteristics were not significantly different in the two groups.
        • Number of patients (n): 252
        • Primary endpoint: Percent diameter stenosis (%DS) at 6-8 months

        PEBSI RCT

        • Prospective, multi-center, randomized, investigator-initiated trial to compare the efficacy and safety of the combined treatment of BMS plus DCB versus the conventional treatment (BMS only) in patients with STEMI within 12 hours of symptom onset. Baseline characteristics were similar in both groups
        • Number of patients (n): 223
        • Primary angiographic endpoint: 9-month late lumen loss (LLL)

        PEPPER Registry

        • Prospective, multi-center, non-randomized European clinical trial
        • Number of patients (n): 81
        • Primary endpoint: In-stent late lumen loss (LLL) at 6 months

        Technical Data

        Drug-Releasing Balloon
        Catheter type
        Fast-exchange PTCA balloon catheter
        Recommended guide catheter5F (min. I.D. 0.056”)
        Lesion entry profile
        0.017”
        Guide wire diameter
        0.014”
        Usable catheter length
        140 cm
        Balloon folding
        3-fold
        Ballon markersTwo embedded platinum-iridium markers
        Brachial shaft marker 92 cm from tip
        Femoral shaft marker
        102 cm from tip
        Proximal shaft diameter
        2.0 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 Pressure atm51313131312
        (RBP)ø (mm)2.262.823.484.114.59

        Ordering Information


        Contact

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        Country/Region

        1 Indications may differ in countries not accepting CE mark.

        2 Hehrlein C et al. Cardiovasc Revasc Med. 2012 Sep;13(5):260-4.

        3 Toelg R et al. EuroIntervention 2014 Sep;10(5):591-9.

        4 Joner et al. Thrombosis and Haemostasis. 2011 May;105(5):864-72.

        5 1 atm = 1.013 bar