product
Passeo®-18 Lux® Drug-Coated Balloon
Passeo®-18 Lux® DCB (drug-coated balloon) is indicated to dilate de novo or restenotic lesions in the infrainguinal arteries.*
*Indication as per IFU. ** not available for sale in the US.
Why to use it
• 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.1-3
• For Challenging Patient Groups: Safety and efficacy clinically proven across challenging subgroups in BIOLUX P-III all-comers registry.3
• Effective Drug Delivery: Reduction of drug loss with SafeGuard™ Insertion Aid and high drug retention with BIOTRONIK’s Lux® hydrophobic coating.4
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. Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry. Cardiovasc Intervent Radiol.2021;44:207-217; 4. BIOTRONIK data on file.
Passeo, Lux and Safeguard are trademarks or registered trademarks of the BIOTRONIK Group of Companies.
Characteristics
| Drug-Coated Balloon Technical Data | |
|---|---|
| Catheter Type | OTW |
| Recommended Guidewire | 0.018" |
| Tip | Short, tapered |
| Balloon Markers | 2 swaged markers (zero profile) |
| Shaft | 3.8F, hydrophobic coated |
| Usable Length | 90, 130 cm; 150 cm (only ø 2.0 mm) |
| Introducer Size | 4F (ø 2.0 - 4.0 mm); 5F (ø 5.0 - 7.0 mm) |
| Nominal Pressure | 6 atm |
| Rated Burst Pressure | 15 atm (ø 2.0 - 5.0 mm); 12 atm (ø 6.0 - 7.0 mm) |
| Coating Technical Data | |
|---|---|
| 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 |
