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
    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); 12 atm (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

    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
    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); 12 atm (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 2.5 x ø 3.0 x ø 4.0 x ø 5.0 x ø 6.0 x ø 7.0 x
    40-120 40-120 40-120 40-120 40-120 40-120 40-120
    Nominal Pressure (NP) atm** 6 6 6 6 6 6 6
    ø (mm) 2.0 2.5 3.0 4.0 5.0 6.0 7.0
    Rated Burst Pressure (RBP) atm** 15 15 15 15 15 15 15
    atm**

    ø (mm)    		 2.1 2.6 3.2 4.3 5.3 6.2 7.3
    **1 atm = 1.013 bar

    Ordering Information

     

      Catheter

    Length (cm)    		 Balloon

    ø (mm)

    Balloon Length

    (mm)
        40 80 120
    4F 90 2.0 379860 379861 379862
    90 2.5 379866 379867 379868
    90 3.0 370843 370848 370853
    90 4.0 370844 370849 370854
    5F 90 5.0 370845 370850 370855
    90 6.0 370846 370851 370856
    90 7.0 370847 370852 370857
    4F 150 2.0 379863 379864 379865
    130 2.5 379869 379870 379871
    130 3.0 370858 370863 370868
    130 4.0 370859 370864 370869
    5F 130 5.0 370860 370865 370870
    130 6.0 370861 370866 370871
    130 7.0 370862 370867 370872

     

    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

    Media

    Product Animations

    Passeo-18 Lux DCB - Clinically proven results in more than 1900 patients
    Passeo-18 Lux DCB - Effective drug delivery with clinically proven results

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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.