Passeo-18 Lux

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

Passeo-18 Lux

 

 


 

 

Clinically proven

 

 

Randomized controlled and all-comers registry clinical data investigated safety and efficacy in the treatment of femoropopliteal and infrapopliteal arteries.

 

 

 

 


 

 

Safe and effective

 

 

BIOLUX P-I1 Femoropopliteal Indication

 

 


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


 

 

BIOLUX P-II2 Infrapopliteal Indication

 

 


Major Adverse Events (MAE)
Passeo-18 Lux 30 days MAE rate was lower compared to the control PTA balloon.


*PTA - Percutaneous Transluminal Angioplasty

 


 

 

Proven in a real-world setting

 

 

 

BIOLUX P-III3 all-comers Superficial Femoral Artery (SFA) 12-month results in 441 patients.


 

 

 

 


 

 

Proven in more calcified lesions and more challenging patients (12-month SFA data)




Fcd-TLR - Freedom from clinically driven Target Lesion Revascularization as Kaplan Meier estimate; PP - Primary Patency as Kaplan Meier estimate; CLI- Critical Limb Ischemia

 


 

 

Effective drug delivery to the lesion

 

 

 

Insertion and handling

 

 

 

The SafeGuard 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.


 

 


 


 

 

Tracking

 

Passeo-18 Lux hydrophobic Butyryl-tri-hexyl citrate (BTHC) excipient is less soluble than hydrophilic alternatives, ensuring more drug is available at the lesion site.

 


 

 

 

 


 

 

Effective tissue absorption and prolonged drug presence

 

 

 

At the lesion site

 

 

 

BTHC excipient keeps paclitaxel in microcrystalline structure, ensuring efficient drug transfer and prolonged bioavailability at the lesion site.9

 

 

 


 

 

Paclitaxel Vessel Concentration9


 

 


 

 

Passeo-18 Lux


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

Media

Passeo-18 Lux

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


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 Pressureatm86666666
(NP)ø (mm)2.02.53.04.05.06.07.0
Rated Burst Pressureatm815151515151212
(RBP)ø (mm)2.12.63.34.35.26.37.2

Ordering Information

2.0 (4F)379860379861379862
2.5 (4F)379866379867379868
3.0 (4F)370843370848370853
4.0 (4F)370844370849370854
5.0 (5F)370845370850370855
6.0 (5F)370846370851370856
7.0 (5F)370847370852370857
2.5 (4F)379869379870379871
3.0 (4F)370858370863370868
4.0 (4F)370859370864370869
5.0 (5F)370860370865370870
6.0 (5F)370861370866370871
7.0 (5F)370862370867370872
2.0 (4F)379863379864379865

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 Tepe G. BIOLUX P-III 12-month results, SFA subgroup analysis. Presented at CIRSE 2017;

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. The 24-month Results of the Lutonix global SFA registry worldwide experience with Lutonix Drug-Coated Balloon. JACC: Cardiovascular Interventions. 2017:10:16:1691-1693;

6 IN.PACT global full clinical cohort. Presented by M. R. Jaff at VIVA 2016;

7 BIOTRONIK data on file;

8 BIOTRONIK data on file;

9 BIOTRONIK data on file.

Stellarex is a registered trademark of Spectranetics; Lutonix is a registered trademark of C. R. Bard; IN.PACT and Admiral are registered trademarks of Invatec.

*Indication as per IFU.