Vascular Intervention // Peripheral
Drug-Coated Balloon Catheter/0.018''/OTW
Clinically proven results in challenging patient groups
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.
Indicated to dilate de novo or restenotic lesions in the infrainguinal arteries.*
|Recommended guide wire
||2 swaged markers (zero profile)
||3.8 F, hydrophobic coated
||90, 130 cm; 150 cm (only ø 2.0 mm)
||4 F (ø 2.0 - 4.0 mm); 5F (ø 5.0 - 7.0 mm)
|Nominal Pressure (NP)
|Rated Burst Pressure (RBP)
||15 atm (ø 2.0 - 5.0 mm); 12 atm (ø 6.0 - 7.0 mm)
||Paclitaxel and butyryl-tri-hexyl citrate (BTHC)
||Cylindrical section of the balloon, exceeding the proximal and distal markers
|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|
|Rated Burst Pressure||atm**||15||15||15||15||15||12||12|
**1 atm = 1.013 bar
|Catheter Length (cm)||Balloon ø (mm)||Balloon Length (mm)|
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.