Passeo-18 Lux

Vascular Intervention // Peripheral
Drug-Coated Balloon Catheter/0.018''/OTW

Passeo®-18 Lux®

Clinically proven results in challenging patient groups




 

 


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.

 


Safe and effective


BIOLUX P-I RCT1 Femoropopliteal Indication


12-month Target Lesion Revascularization (TLR)
Passeo-18 Lux DCB significantly reduced TLR rates compared to the control PTA* balloon in the as-treated population.


 

BIOLUX P-II2 Infrapopliteal Indication


Major Adverse Events (MAE)
MAE rate of the Passeo-18 Lux DCB was lower compared to the control PTA balloon.




BIOLUX P-III2 All-Comers Registry


Passeo-18 Lux DCB demonstrates excellent outcomes in one of the largest real-world DCB registries with few exclusion criteria.


Kaplan-Meier estimates; RC - Rutherford Classification; cd-TLR - clinically driven Target Lesion Revascularization.


For challenging patient groups


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

 



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.

 


Effective drug delivery

 


Insertion and handling

The SafeGuardTM insertion aid improves ease of handling, and protects the user and balloon coating from contact and damage. It comes pre-mounted on the balloon and, after insertion, can simply be retracted and peeled away.

 


Reduction of drug loss in the introducer sheath valve11



 

High drug retention11


BIOTRONIK's Lux® coating provides a hydrophobic butyryl-tri-hexyl citrate (BTHC) excipient, which is less soluble than hydrophilic alternatives, ensuring more drug is available at the lesion site.


Drug coating integrity: % of drug load remaining on balloon after being submerged for ~90 seconds in physiological solution.

 



 

Passeo®-18 Lux®

Indicated to dilate de novo or restenotic lesions in the infrainguinal arteries.*


Technical Data

Drug-coated balloon
Catheter type
OTW
Recommended guide wire
0.018"
Tip
Short, tapered
Balloon markers
2 swaged markers (zero profile)
Shaft
3.8 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)
Coating
Drug
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)
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 atm** 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 atm** 15 15 15 15 15 12 12
(RBP) 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)
4080120
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

Contact

contact
Country/Region

1. Scheinert D, et al. Paclitaxel Releasing Balloon in Femoropopliteal lesions using a BTHC excipient: 12-month results from the BIOLUX P-I randomized trial. JEVT. 2015; 22(1): 14-21;

2. 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;

3. Schroë, Herman, et al. Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study. Catheterization and Cardiovascular Interventions 91.3;

4 Schroe H. Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease - The ILLUMENATE Global Study: 12-month results from a prospective, multicenter, singlearm
study. Catheter Cardiovasc Interv. 2017; 1-8;

5 Thieme M et al. The 24-month results of the Lutonix Global SFA Registry: worldwide experience with Lutonix drug-coated balloon. JACC: Cardiovasc Interv. 2017;10:1682-1690;

6 Zeller T. Drug-coated balloon treatment of femoropopliteal lesions for patients with intermittent claudication and ischemic rest pain. Circulation: Cardiovasc Interv. 2019;12:e007730;

7 Lichtenberg M, von Bilderling P, Ranft J et al. Treatment of Femoropopliteal Atherosclerotic Lesions using the Ranger PTX - 12m results, All-Comers. JCV 2017. doi: 10.23736/S0031-9509.17.10261-2;

8 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;

9 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;

10 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; 11. BIOTRONIK data on file.

*Indication as per IFU. 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.