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Europe, Middle East, Africa / Product Areas / Interventional Cardiology & Radiology / Peripheral Interventions / Passeo-18 Lux

Passeo™-18 Lux™ DCB

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.


Product Highlights

Clinically Proven

Safe and effective in the treatment of lower limb arteries2,3

For Challenging Patient Groups4

Excellent results despite a complex population at baseline4

Effective Drug Delivery

Reduction of drug loss with SafeGuard™ Insertion Aid1

Deliverability icon

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.

Deliverability icon

For Challenging Patient Groups

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

Deliverability icon

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

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

BIOLUX P-I

84.6% Freedom from TLR at 12 months

Clinical trial to asses the safety and performance of the coated Passeo-18 Lux paclitaxel-releasing PTA balloon catheter versus the uncoated Passeo-18 balloon catheter for treatment of stenosis of the femoropopliteal arteries

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BIOLUX P-II

0.0% MAE composite at 30 days

Clinical trial to asses the safety and performance of the coated Passeo-18 Lux paclitaxel-releasing PTA balloon catheter versus the uncoated Passeo-18 balloon catheter for treatment of stenosis of the femoropopliteal arteries

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BIOLUX P-II

82.9% PP vs 73.9% compared to the control PTA balloon at 6 months

First-in-human study to assess the safety and performance of the Passeo-18 Lux drug coated balloon vs. the uncoated Passeo-18 catheter in patients with stenosis and occlusion of the infrapopliteal arteries

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BIOLUX P-III

42.1% Critical limb ischemia patients

Prospective, international, multicenter, all-comers registry investigating safety and efficacy data on the Passeo-18 Lux DCB in a real-world population with atherosclerotic disease of the infaringuinal arteries

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BIOLUX P-III

96.5% Freedom from Major Target Limb Amputation at 24 months

Prospective, international, multicenter, all-comers registry investigating safety and efficacy data on the Passeo-18 Lux DCB in a real-world population with atherosclerotic disease of the infaringuinal arteries

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BIOLUX P-III

88.1% Freedom from cd-TLR at 24 months

Prospective, international, multicenter, all-comers registry investigating safety and efficacy data on the Passeo-18 Lux DCB in a real-world population with atherosclerotic disease of the infaringuinal arteries

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Product Overview

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
  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 2 2.5 2.5 3 3 4 4 5 5 5 6 7
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
  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

IFU Link

Refer to this IFU link for a copy of the Instructions for Use and for a complete listing of the indications, contraindications, warnings and precautions.

References:

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. 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.

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

Teleflex, the Teleflex logo, Lux, Passeo and SafeGuard are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other names are the trademarks or registered trademarks of their respective owners. Refer to this IFU link for a copy of the Instructions for Use and for a complete listing of the indications, contraindications, warnings and precautions. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries. ©2025 Teleflex Incorporated. All rights reserved.