Passeo-18 Lux

Vascular Intervention // Peripheral
Drug-Coated Balloon Catheter/0.018''/OTW

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.

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

 

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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.

 

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Effective drug delivery

 

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Insertion and handling

The SafeGuard^TM 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

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High drug retention¹¹

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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.

 

 

 

Passeo^®-18 Lux^®

Indicated to dilate de novo or restenotic lesions in the infrainguinal arteries.*

 

 

Technical Data

Drug-coated balloon
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)
Coating
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

Compliance Chart

		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
		40-120	40-120	40-120	40-120	40-120	40-120	40-120
Nominal Pressure	atm**	6	6	6	6	6	6	6
(NP)	ø (mm)	2.0	2.5	3.0	4.0	5.0	6.0	7.0
Rated Burst Pressure	atm**	15	15	15	15	15	12	12
(RBP)	ø (mm)	2.1	2.6	3.2	4.3	5.3	6.2	7.3

 

^**1 atm = 1.013 bar

Ordering Information

	Catheter Length (cm)	Balloon ø (mm)	Balloon Length (mm)
			40	80	120
4F	90	2.0	379860	379861	379862
	90	2.5	379866	379867	379868
	90	3.0	370843	370848	370853
	90	4.0	370844	370849	370854
5F	90	5.0	370845	370850	370855
	90	6.0	370846	370851	370856
	90	7.0	370847	370852	370857
4F	150	2.0	379863	379864	379865
	130	2.5	379869	379870	379871
	130	3.0	370858	370863	370868
	130	4.0	370859	370864	370869
5F	130	5.0	370860	370865	370870
	130	6.0	370861	370866	370871
	130	7.0	370862	370867	370872