Passeo-18 Lux

Image of Passeo-18 Lux
Passeo-18 Lux Drug-Coated Balloon
Image of Passeo-18 Lux
Passeo-18 Lux Drug-Coated Balloon
Image of Passeo-18 Lux
Passeo-18 Lux Drug-Coated Balloon
Image of Passeo-18 Lux
Passeo-18 Lux Drug-Coated Balloon

Passeo®-18 Lux®


Indicated for lower limb arteries. The Passeo®-18 Lux® drug-coated balloon - an advanced therapy to expand conventional PAD treatment options - proven to inhibit restenosis while maintaining a high safety profile.

  • Clinically proven to reduce restenosis and the need for reinterventions1
  • Lux coating technology optimizes drug transfer for maximized efficacy
  • Low profile, highly deliverable Passeo-18 balloon platform
  • Innovative SafeGuard insertion aid for unrivaled safety and ease of handling


Product Details

Safe and Effective

Robust, high-quality clinical data demonstrate Passeo®-18 Lux® safety and efficacy in the treatment of femoropopliteal and infrapopliteal arteries.

Passeo-18 Lux image

BIOLUX P-I2,3 Femoropopliteal Indication

6-month Binary Restenosis:
Passeo®-18 Lux® significantly reduced Binary Restenosis compared to the control PTA balloon (p = 0.048*).

*p < 0.05 is significant

Passeo-18 Lux image

12-month Target Lesion Revascularization4:
Passeo®-18 Lux® significantly reduced Target Lesion Revascularization rates compared to the control PTA balloon (p = 0.020*).

*p < 0.05 is significant

Passeo-18 Lux image

BIOLUX P-II3, 5 Infrapopliteal Indication

6-month change in Rutherford Class:
Passeo®-18 Lux® improved Rutherford Class compared to the control PTA balloon.

Passeo-18 Lux image

12-month Major Amputation:
Passeo®-18 Lux® Major Amputation rate was lower compared to the control PTA balloon. In the DCB group, it was 3.3 % at 6 months and no additional amputation occurred after 180 days.

Optimized Coating Formulation

The Lux coating technology provides an optimal delivery mechanism, ensuring minimal drug loss during tracking and inflation, rapid drug transfer to the vessel wall and a sustained therapeutic effect.6

  • Drug: 3 μg/mm2 paclitaxel anti-proliferative agent
  • Excipient: butyryl-tri-hexyl citrate (BTHC) hydrophobic carrier improves coating integrity so that more drug is available at the lesion site. Safe and biocompatible.
  • Coating process: homogeneous balloon coating shelters drug within the balloon folds and ensures drug transfer to the entire region treated.

Low Profile Delivery Platform

Passeo®-18 Lux® is part of BIOTRONIK 4F solutions. It is based on the Passeo-18 low profile balloon platform, thus minimizing the risk of access site complications7 and improving lesion crossing performance.

SafeGuard – Improved and Safer Handling

SafeGuard insertion aid improves ease of handling and protects the user and balloon coating from contact and damage. It is pre-mounted on the balloon and after use, it can simply be peeled away.


Passeo®-18 Lux®

This video demonstrates how the clinically-proven Passeo®-18 Lux® treats de novo and restenotic lesions in the infrainguinal arteries.


  • Prospective, multi-center, 1:1 randomized, controlled trial enrolling 60 patients at five clinical sites in Germany and Austria.
  • Number of patients (n): 60
  • Primary endpoint: 6-month LLL in target lesion measured by quantitative vascular angiography (QVA) by an independent corelab


  • Prospective, multi-center, randomized controlled, first-in-human study
  • Number of patients (n): 72
  • Primary endpoint: 30-day MAE rate2, 6-month TLP measured by quantitative vascular angiography (QVA)


  • Prospective, multi-center, investigator-initiated registry to evaluate the implantation outcome of the Pulsar-18 stent followed by Passeo®-18 Lux® DCB in the femoropopliteal arteries.
  • Number of patients (n): 65 (12-month data available on n 51)
  • Primary endpoint: PP at 12 and 24 months, defined as a binary duplex ultrasound ratio PSVR <2.5 at the stented target lesion with no clinically-driven reintervention within the stented segment.

Technical Data

Passeo®-18 Lux®
Catheter type
Recommended guide wire
Short, tapered
Balloon markers
2 swaged markers (zero profile)
3.8 F, hydrophobic coated
Usable length
90, 130 cm; 150 cm (only ø 2.0 mm)
Introducer size
4 F (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 Coating
Drug concentration
3.0 μg/mm2
Coating matrix
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)
Nominal Pressure atm8 6 6 6 6 6 6 6
(NP) ø (mm) 2.0 2.5 3.0 4.0 5.0 6.0 7.0
Rated Burst Pressure atm8 15 15 15 15 15 12 12
(RBP) ø (mm) 2.1 2.6 3.3 4.3 5.2 6.3 7.2

Ordering Information



The DCB with its Lux® coating is part of the family of Paclitaxel-coated balloons from BIOTRONIK.
Passeo and Lux are trademarks or registered trademarks of the BIOTRONIK Group of Companies.

1 BIOLUX P-I and BIOLUX P-II Randomized Clinical Trials

2 Scheinert D, et al. BIOLUX P-I. JEVT. 2015; 22(1): 14-21.

3 Selected endpoints

4 As-Treated population

5 Zeller et al. BIOLUX P-II. J Am Coll Cardiol Intv. 2015; 8: 1614-22.

6 Pre-clinical data on file at BIOTRONIK AG

7 Bosiers M, et al. 4-French–Compatible Endovascular Material Is Safe and Effective in the Treatment of Femoropopliteal Occlusive Disease. Results of the 4EVER Trial. J Endovasc Ther. 2013; 20(6): 746-756.

8 1 atm = 1.013 bar