Teleflex acquires substantially all of BIOTRONIK Vascular Intervention business

The BIOTRONIK Vascular Intervention business, with the exception of IMDS products has been acquired by Teleflex, effective as of July 1st, 2025. These products are now part of the Teleflex portfolio. For questions or further information relating to the Vascular Intervention portfolio, please complete the contact form below.

    Passeo®-18 Lux®

    Clinically proven results in challenging patient groups

    The Passeo-18 Lux Drug-Coated Balloon is indicated to dilate de novo or restenotic lesions in the infrainguinal arteries* through a low profile** balloon platform. Its technologies allow an effective drug delivery1: The SafeGuard® Insertion Aid reduces drug loss in the introducer sheath up to 94% and protects user and balloon from contact and damage, while the Lux® Coating (Paclitaxel and BTHC) optimizes drug transfer and ensures high drug retention at the lesion site.

    Category

    Vascular Intervention Peripheral PVI Drug-Coated Balloon

    Product Highlights

    Clinically Proven

    Safe and effective in the treatment of lower limb

    arteries2⸴3

    For Challenging Patient Groups

    Excellent results despite a complex population at

    baseline4

    Effective Drug Delivery

    Reduction of drug loss with SafeGuard® Insertion Aid1

    Clinically Proven

    Randomized controlled trials and all-comers registries have investigated safety and efficacy in the treatment of over 1,900 patients with peripheral artery disease (PAD) in the femoropopliteal and infrapopliteal arteries.

    BIOLUX P-I RCT² Femoropopliteal Indication¹⁰

    Significantly reduced Target Lesion Revascularization (TLR) at 12 months compared

    to the control PTA* balloon in the as-treated population²

    BIOLUX P-II RCT³ Infrapopliteal Indication

    Major Adverse Events (MAE) rate of the Passeo-18 Lux DCB was lower compared to the control PTA balloon.

    BIOLUX P-III⁴ All-Comers Registry

    Passeo-18 Lux DCB demonstrates excellent outcomes in one of the largest real-world DCB registries with few exclusion criteria.

    For challenging patient groups

    Safety and efficacy clinically proven across challenging subgroups in BIOLUX P-III all-comers registry.

    Effective Drug Delivery

    Effective drug delivery to the lesion with SafeGuard® insertion aid and the hydrophobic BTHC excipient as part of the Lux® Coating.

    Reduction of drug loss in the introducer sheath valve⁴

    The SafeGuard® insertion aid improves ease of handling and protects the user and the Lux® Coating on the balloon from contact and damage.

    High drug retention¹

    BIOTRONIK's Lux® coating provides a hydrophobic BTHC excipient, which is less soluble than hydrophilic alternatives, ensuring more drug is available at the lesion site.

    Clinical Highlights

    Product Overview

    Passeo-18 Lux

    Technical Data

    Drug-coated balloon  
    Catheter type OTW
    Recommended guide wire 0.018”
    Tip Short, tapered
    Balloon markers 2 swaged markers (zero profile)
    Shaft 3.8F, hydrophobic coated
    Usable Length 90, 130 cm; 150 cm (only ø 2.0 mm)  
    Introducer size 4F (ø 2.0 - 4.0 mm); 5F (ø 5.0 - 7.0 mm)
    Nominal Pressure (NP) 6 atm
    Rated Burst Pressure (RBP) 15 atm (ø 2.0-5.0 mm, L 40-120; ø 2.0-4.0 mm, L 150 mm);
    14 atm (ø 2.0-3.0 mm, L 200 mm);
    13 atm (ø 4.0-5.0 mm, L 200 mm);
    12 atm (ø 5.0 mm, L 150 mm; ø 6.0, 7.0 mm)
    Coating  
    Drug Paclitaxel
    Drug concentration                                         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 * Length (mm)
      ø 2.0 x ø 2.0 x ø 2.5 x ø 2.5 x ø 3.0 x ø 3.0 x ø 4.0 x ø 4.0 x ø 5.0 x ø 5.0 x ø 5.0 x ø 6.0 x ø 7.0 x
    40-150 200 40-150 200 40-150 200 40-150 200 40-120 150 200 40-200 40-200
    Nominal Pressure (NP) atm** 6 6 6 6 6 6 6 6 6 6 6 6 6
    ø (mm) 2.0 2.0 2.5 2.5 3.0 3.0 4.0 4.0 5.0 5.0 5.0 6.0 7.0
    Rated Burst Pressure (RBP) atm** 15 14 15 14 15 14 15 13 15 12 13 12 12
    atm**
    ø (mm)    		 2.1 2.1 2.6 2.6 3.2 3.2 4.3 4.2 5.3 5.2 5.2 6.2 7.3
    **1 atm = 1.013 bar

    Ordering Information

     

      Catheter
    Length (cm)    		 Balloon
    ø (mm)    		 Balloon Length
    (mm)    		    
        40 60 80 100 120 150 200
    4F 90 2.0 379860 - 379861 - 379862 449970 449977
    90 2.5 379866 - 379867 - 379868 449971 449978
    90 3.0 370843 484199 370848 484206 370853 449972 449979
    90 4.0 370844 484200 370849 484207 370854 449973 449980
    5F 90 5.0 370845 484201 370850 484208 370855 449974 449981
    90 6.0 370846 484202 370851 484209 370856 449975 449982
    90 7.0 370847 484203 370852 484210 370857 449976 449983
    4F 150 2.0 379863 484211 379864 484218 379865 449984 449991
    130 2.5 379869 484212 379870 484219 379871 449985 449992
    130 3.0 370858 484213 370863 484220 370868 449986 449993
    130 4.0 370859 484214 370864 484221 370869 449987 449994
    5F 130 5.0 370860 484215 370865 484222 370870 449988 449995
    130 6.0 370861 484216 370866 484223 370871 449989 449996
    130 7.0 370862 484217 370867 484224 370872 449990 449997

     

    Downloads and Related Links

    Downloads

    Download Brochure Download IFU Endovascular Today Supplement - Expert cases on CTO management

    Related Links

    Newsroom More information about Passeo-18 Lux DCB

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    References

    The Passeo®-18 Lux® DCB with its Lux® coating is part of the Lux® family of Paclitaxel-coated balloons from BIOTRONIK.

    PTA - Percutaneous Transluminal Angioplasty; RCT: Randomized Controlled Trial; MAE: Major Adverse Events; cd-TLR: clinically driven Target Lesion Revascularization.

    MA - Major target limb Amputations; Δ Moderate/Severe Calcified Lesions; ф Defined as composite of device - and procedure-related mortality through 30 days, and major target limb amputation and clinically driven target lesion revascularization. 

    BTHC = hydrophobic butyryl-tri-hexyl citrate

    TLR = Target Lesion Revascularization; MAE = Major Adverse Event; PP = Primary Patency; PTA = Percutaneous Transluminal Angioplasty; BMS = Bare-Metal Stent; cd-TLR = clinically-driven Target Lesion Revascularization.

    * Indication as per IFU. **Passeo-18 Balloon platform. Passeo-18 Lux Introducer size: 4F (⌀2.0-4.0 mm) ; 5F (⌀ 5.0-7.0 mm). BTHC = hydrophobic butyryl-tri-hexyl citrate

    1. BIOTRONIK data on file; 2. Scheinert D. Paclitaxel Releasing Balloon in femoropopliteal lesions using BTHC excipient: 12-month results from the BIOLUX P-I randomized trial. JEVT, 2015; 22(1): 14-21; 3. Zeller et al. Paclitaxel-Coated Balloon in Infrapopliteal arteries 12-month results from the BIOLUX P-II randomized trial. J Am Coll Cardiol Intv. 2015; 8: 1614-22; 4. Tepe G. Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry. Cardiovasc Intervent Radiol.2021;44:207-217; 5. Brodmann B et al. Real-World Experience With a Paclitaxel-Coated Balloon in Critical Limb Ischemia 24-Month Subgroup Outcomes of BIOLUX P-III. JACC Cardiovasc Interv. 2020;13:2289-2299; 6. Tepe G et al. BIOLUX P-III Passeo-18 Lux All-Comers Registry: 24-Month Results in Below-the-Knee Arteries. Cardiovasc Intervent Radiol. 2021;44:10-18; 7. Mwipatayi P, Barry I, Brodmann M, et al. Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis. Annals of Vascular Surgery (2021); https://doi.org/10.1016/j.avsg.2021.02.050.

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