Vascular Intervention // Peripheral
Drug-Coated Balloon Catheter/0.018''/OTW
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.
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
Indicated to dilate de novo or restenotic lesions in the infrainguinal arteries.*
|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 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|
|Balloon Diameter x Length (mm)|
|Rated Burst Pressure||atm8||15||15||15||15||15||12||12|
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.