Pantera® Lux®

    Clinically proven. Best in class crossability.

    Pantera Lux Coronary Drug-Coated Balloon (DCB) is indicated for balloon dilatation for in-stent restenosis, de novo lesions, acute or impending vascular occlusion and treatment of small vessel disease.a 

    Category

    Vascular Intervention Coronary CVI Drug-Coated Balloon

    Product Highlights

    Clinically proven solution

    For in-stent-restenosis and further indications1-12

    Lux®coating technology

    For rapid drug absorption13

    Excellent deliverability

    Lowest crossing profile for better push and easier cross14

    Clinically proven solution

    Clinical outcomes from multiple studies including randomized controlled trials like BIOLUX RCT, ISARDESIRE 4 and PEBSI show high efficacy and safety for both in-stent restenotic and de novo lesions.1-12

    More than 3,900 patients treated in clinical studies1-12,15-16

    Pantera Lux DCB has proven efficacy and safety in multiple clinical trials investigating coronary drug-coated balloons for various implant-free treatment options.1-10

    BIOLUX RCT (n=229)⁴

    DCB is confirmed as a viable treatment option for ISR with the advantage of avoiding an additional stent layer. 

    REVELATION (n=120)⁸

    The treatment with Pantera Lux DCB may represent a valuable alternative strategy in selected STEMI patients undergoing primary PCI.

    Lux® coating technology for rapid drug absorption

    The Lux coating technology blends paclitaxel with BTHC, a rapidly metabolized, safe and biocompatible excipient, thus improving bioavailability at the target site.13 

    Prolonged tissue retention at the target site

    Following one application of the Pantera Lux DCB, paclitaxel can be readily detected in the treated region beyond 7 days in animal tissue.13,14

    Excellent deliverability

    Pantera Lux DCB, with its lowest crossing profile, provides better pushability and easier crossability.14

    Lowest crossing profile¹⁴

    Pantera Lux DCB has a 44% smaller crossing profile. 

    Better pushability¹⁴

    136% more force transmitted from hub to distal tip.

    Best in class crossability¹⁴

    82% less force needed to cross lesions.

    Clinical Highlights

    Product Overview

    Pantera Lux

    Technical Data

    Drug-coated balloon catheter
    Catheter type Fast-exchange PTCA balloon catheter
    Recommended guide catheter 5F (min. I.D. 0.056”)
    Lesion entry profile 0.017”
    Guide wire diameter 0.014”
    Usable catheter length 140 cm
    Balloon folding 3-fold
    Balloon markers Two embedded platinum-iridium markers
    Brachial shaft marker 92 cm from tip
    Femoral shaft marker 102 cm from tip
    Proximal shaft diameter 2.0F
    Distal shaft diameter 2.5F (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
    Drug Paclitaxel
    Drug dose 3.0 μg/mm2
    Coating matrix Lux® coating comprising Paclitaxel and Butyryl-tri-hexyl citrate (BTHC)
    Coated area Cylindrical section of the balloon, exceeding the proximal and

    distal markers

    Compliance Chart

        Balloon diameter x length (mm)    
        ø 2.0 x 10-30   ø 2.5 x 10-30   ø 3.0 x 10-30   ø 3.5 x 10-30  ø 4.0 x 10-30 
    Nominal Pressure

    (NP)    		 atm* 7 7 7 7 7
    ø (mm) 2.00 2.50 3.00 3.50 4.00
    Rated Burst Pressure

    (RBP)    		 atm* 13 13 13 13 12
    ø (mm) 2.26 2.82 3.48 4.11 4.59
    *1 atm = 1.013 bar

    Ordering Information

    Balloon

    ø (mm)    		 Catheter length 140cm

    Balloon length (mm)
      10 15 20 25 30
    2.0 365110 365111 365112 365113 365114
    2.5 365120 365121 365122 365123 365124
    3.0 365125 365126 365127 365128 365129
    3.5 365130 365131 365132 365133 365134
    4.0 365135 365136 365137 365138 365139

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    References

    The Pantera® Lux® DCB with its Lux® coating is part of the Lux® family of Paclitaxel-coated balloons from BIOTRONIK.

    a. Indications as per IFU, it may differ in countries not accepting CE mark; b. Orsiro (BIOTRONIK); c. Orsiro (BIOTRONIK) or Xience (ABBOTT); d. Compared to SeQuent and IN.PACT Falcon.

    1. Tölg R et al. Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry EuroIntervention. 2014; 10(5). 591-599; 2. Hehrlein C et al. Twelve-month results of a Paclitaxel Releasing Balloon in Patients Presenting with In-stent Restenosis First-in-Man (PEPPER) trial. Cardiovascular Revascularization Medicine. 2012; 13 (5): 260-264; 3. Kufner S, Joner M, Schneider S et al. Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents. JACC Cardiovasc Interv. 2017; 10(13). 1332 -1340; 4. Jensen C et al. Angiographic and clinical performance of a paclitaxel-coated balloon compared to a second-generation sirolimus-eluting stent in patients with in-stent restenosis: the BIOLUX randomised controlled trial. EuroIntervention. 2018; 14: 1096-1103; 5. Nguyen V.P.T et al. Comparison of clinical outcomes of two different types of paclitaxel-coated balloons for treatment of patients with coronary in-stent restenosis. Heart and Vessels. 2019. 1-9. doi: 10.1007/s00380-019-01388; 6. Assadi-Schmidt A et al. SeQuent Please vs. Pantera Lux drug coated balloon angioplasty in real life: Results from the Düsseldorf DCB registry, Int J Cardiol. 2016. doi: 10.1016/j.ijcard.2016.12.022; 7. Vos NS et al. Safety and feasibility of a Paclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one year clinical outcome of a pilot study. EuroIntervention. 2014; 10(5). 584 -590; 8. Vos N S et al. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction (The REVELATION Randomized Trial). JACC: Cardiovascular Interventions. 2019; 1-9, doi:10.1016/j.jcin.2019.04.016; 9. Worthley S, Hendriks R, Worthley M et al. Paclitaxel-eluting balloon and everolimus-eluting stent for provisional stenting of coronary bifurcations: 12-months results of the multicenter BIOLUX-I study. Cardiovasc Revasc. Med. 2015; 16(7). 413 -417; 10. Jim MH et al. Six month angiographic result of supplementary paclitaxel-eluting balloon deployment to treat side branch ostium narrowing (SARPEDON). Int J Cardiol. 2015; 187:594 -597; 11. Roncalli J et al. Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial). J INVASIVE CARDIOL. 2019;31(4):94-100; 12. García-Touchard A, Goicolea J, Sabaté M et al. A randomised trial of paclitaxel-eluting balloon after bare metal stent implantation vs. bare metal stent in ST-elevation myocardial infarction (the PEBSI study). EuroIntervention. 2017; 12(13). 1587 -1594; 13. Radke P W et al. Vascular effects of paclitaxel following drug-eluting balloon angioplasty in a porcine coronary model: the importance of excipients. EuroIntervention. 2011; 7 (6): 730-737.pdf; 14. BIOTRONIK data on file; 15. Galli S et al. Results of paclitaxel-drug-coated balloons (Pantera Lux) for coronary in-stent restenosis: Italian experience from REGistry of Paclitaxel Eluting Balloon in ISR study. Italian Federation of Cardiology. 2021. doi:10.2459/JCM.0000000000001127; 16. Venetsanos D, Omerovic E, Sarno G et al. Long term outcome after treatment of de novo coronary artery lesions using three different drug coated balloons. International Journal of Cardiology. 2020; 1-7. doi: 10.1016/j.ijcard.2020.09.054.



    Pantera and Lux are trademarks or registered trademarks of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owners.