Passeo-18 Lux

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

Passeo-18 Lux

DRUG-COATED BALLOON
INDICATED FOR LOWER LIMB ARTERIES

The Passeo-18 Lux drug-coated balloon is an advanced therapy to expand conventional PAD treatment options and is proven to inhibit restenosis while maintaining a high safety profile.


KEY FACTS
  • Clinically proven to reduce restenosis and the need for reinterventions1
  • Lux coating technology optimises drug transfer for maximised efficacy
  • 4F, 5F and 6F compatible
  • Innovative SafeGuard protection mechanism for clinician safety and ease of handling
  • Low profile, highly deliverable Passeo-18 balloon platform

Product Details

Indicated for lower limb arteries

Robust, high-quality clinical data demonstrate Passeo-18 Lux 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.


Optimised 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 4F, 5F and 6F compatible. It is based on the Passeo-18 low profile balloon platform, thus minimising the risk of access site complications7 and improving lesion crossing performance.


SafeGuard – Improved and Safe Handling

SafeGuard protection mechanism improves handling and protects the clinician and balloon coating from contact and damage. It is pre-mounted on the balloon and can be simply peeled away after use.


Media

Passeo-18 Lux

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


BIOLUX P-I

  • 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

BIOLUX P-II

  • 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)

DEBAS

  • 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
OTW
Recommended guide wire
0.018"
Tip
Short, tapered
Balloon markers
2 swaged markers (zero profile)
Shaft
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
Paclitaxel
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


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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