product
Passeo®-18 Lux™ Drug-Coated Balloon
Passeo®-18 Lux™ 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 and all-comers registry clinical data investigated safety and efficacy in the treatment of femoropopliteal and infrapopliteal arteries.1-3
• Effective Drug Delivery to the Lesion: 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. SafeGuard enables a 95% reduction of drug loss in the introducer sheath valve.4 The 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: BTHC excipient keeps paclitaxel in microcrystalline structure, ensuring efficient drug transfer and prolonged bioavailability at the lesion site.4

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 |
