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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.


Vascular Intervention Peripheral PVI Drug-Coated Balloon

Product Highlights


Clinically Proven

Safe and effective in the treatment of lower limb



For Challenging Patient Groups

Excellent results despite a complex population at



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

Ordering Information



Length (cm)

ø (mm)

Balloon Length


    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



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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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);

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.