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.}

Manufacturer Info

Biotronik BIOTRONIK AG

Ackerstrasse 6

8180 Bülach - Switzerland

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.⁴The 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

^{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. BIOTRONIK data on file.}

^{Passeo and Lux 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