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  • Clinically proven

    Safe and effective in the treatment of lower limb arteries5,6

  • For challenging patient groups

    Excellent results despite a complex population at baseline7

  • Effective drug delivery

    Reduction of drug loss with SafeGuard™ Insertion Aid8

Clinically proven

Safe and effective in the treatment of lower limb arteries1,2

All-comers 24-month outcomes continue to confirm Passeo-18 Lux
DCB‘s safety and effectiveness in infra-inguinal arteries7

Excellent outcomes for the Full-Cohort (877 patients) in one of the largest real-world DCB registries with few exclusion criteria.

  • 41 sites

  • N = 877

  • Primary endpoint: MAE at 6-m*;
    Fcd-TLR at 12-m**

More information about BIOLUX P-III
Know more about the clinical studies with Passeo-18 Lux

Safe and effective in the treatment of peripheral artery disease (PAD)
in the femoropopliteal and infrapopliteal arteries5,6

Randomized Control Trial (Passeo-18 Lux vs PTA balloon), SFA, 60 patients, multi-center

12-month Target Lesion Revascularization (TLR)

Randomized Control Trial (Passeo-18 Lux vs PTA balloon), BTK, 72 patients, multi-center

Major Adverse Events (MAE)

Passeo-18 Lux DCB has similar clinical performance to the IN.PACT Admiral DCB at 2 years follow-up1,2

Passeo-18 Lux DCB demonstrated excellent safety and efficacy at 12 months in BIOPACT RCT1


Continued similar clinical performance was shown between devices at 24 months, with persistent excellence for Passeo-18 Lux2


  • Passeo- 18 Lux
  • IN. PACT Admiral

Equivalent clinical performance, additional benefits1-4

  • Lower-profile 018 platform

    vs. 035 for IN.PACT Admiral DCB

  • 4/5F compatibility

    vs. 5/6/7F for IN.PACT Admiral DCB

  • Lower paclitaxel dosage

    3.0 vs. 3.5 μg/mm2 for IN.PACT Admiral DCB


More information about BIOPACT RCT
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For challenging patient groups

Excellent results despite a complex population at baseline2

Safety and efficacy clinically proven across challenging subgroups in
BIOLUX P-III all-comers registry

BIOLUX P-III Subgroup
Patients
Calcified
lesions∆
RC 5+6
Enrollment
Freedom from
MAE◊,ф (%)
Freedom from
cd-TLR◊ (%)
Freedom from
MA (%)
Femoropopliteal7 592 46.6% 28.9%
Critical limb ischemia9 328 45.0% 68.6%
Below the knee10 151 36.4% 63.6%
Diabetes mellitus11 418 48.3% 40.9%
In-stent restenosis7 103 27.6% 21.2%
12 months
24 months

MA - Major target limb Amputations; ∆ 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.

Access clinical study outcomes
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Effective drug delivery

Reduction of drug loss with SafeGuard™ Insertion Aid8

The SafeGuard™ insertion aid improves ease of handling, and protects
the balloon coating from contact and damage

Reduction of drug loss in the introducer sheath valve7

High drug retention coating with hydrophobic BTHC excipient7

Drug coating integrity: % of drug load remaining on balloon after
being submerged for ~90 seconds in physiological solution.

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Passeo-18 Lux in Action

Case 1: REACT Strategy

REACT Strategy: Drug-Coated Balloon (DCB) +
Bare-Metal Stent (BMS) for a Long SFA Occlusion

Figure 1:
Diagnostic
angiography

Figure 2:
Final results

Patient history

79-year-old male presented with severe claudication and intermittent rest pain of the right leg. Angiography showed a long occlusion of the SFA (Figure 1).

Procedure summary

Predilatation performed with plain angioplasty balloon. Next, three Passeo-18 Lux DCB were used to cover the entire occluded segment, followed by a Pulsar-18 T3 Bare-Metal Stent.

Results

Final angiography showed complete revascularization of the femoropopliteal segment without dissection and fast runoff to the foot (Figure 2).

Request the full case report here
Case 2: Long-term patency

Improving Potential Long-Term Patency
of Common Femoral Artery Stenoses

Figure 3:
Diagnostic
angiography

Figure 4:
Final results

Patient history

66-year-old male presented with impaired walking capacity of the left leg. Angiography confirmed significant stenosis of the left common femoral artery (Figure 3).

Procedure summary

Predilatation performed with plain angioplasty balloon. To improve long-term patency, Passeo-18 Lux DCB was inflated during 3 min.

Results

Final angiography confirmed excellent technical success (Figure 4).

Request the full case report here
Case 3: DCB Treatment for CLI

Drug-Coated Balloon Treatment for
Critical Limb Ischemia

Figure 5:
Diagnostic
angiography

Figure 6:
Results

Patient history

71-year-old man admitted due to critical ischemia of the right lower limb, with painful and non-healing necrosis of the first and second fingers. Diagnosis showed total occlusion of the tibial and dorsal arteries on the right side.

Procedure summary

Angioplasty was performed for 3 minutes in the right posterior tibial artery, in the tibiofibular trunk and in the fibular artery. Angioplasty of the distal PTA and lateral plantar artery was performed with Passeo®-18 Lux®DCB.

Results

Completion angiography demonstrated effective recanalization after use of Passeo-18 Lux DCB, with normal flow to the plantar arch.

Request the full case report here
Case 4: Distal Popliteal DCB Therapy

Distal Popliteal Access for Low-Profile Stenting and DCB Therapy

Figure 1:
Diagnostic
angiography

Figure 2:
Final results

Patient history

A 62-year-old patient presented with a history of multiple interventions on both legs, including amputation and a bypass. Angiography showed an occlusion of the superficial femoral artery.

Procedure summary

Retrograde challenging access and crossing with extravasation. A 4F low-profile Pulsar-18 T3 stent was placed at the ostium of the SFA, distal SFA and popliteal arteries were then treated with Passeo-18 Lux DCB.

Results

Patent SFA with strong outflow into the tibial arteries and a good blood supply into the foot.

Request the full case report here

Watch physician testimonials

Know more about Passeo-18 Lux

Download Brochure

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  • Deloose K. BIOPACT RCT: a third head to head DCB RCT. Presented at Paris Vascular Insights 2022; November 2022; Paris, France;
  • Deloose K. The head-to-head Passeo-18 Lux vs IN.PACT Admiral BIOPACT RCT: latest release of the 24 month outcomes. Presented at: Paris Vascular Insights 2023; November 8-10, 2023; Paris, France;
  • BIOTRONIK data on file;
  • IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter Instructions for Use;
  • Scheinert D. Paclitaxel Releasing Balloon in femoropopliteal lesions using BTHC excipient: 12-month results from the BIOLUX P-I randomized trial. JEVT, 2015; 22(1): 14-21;
  • 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;
  • 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;
  • BIOTRONIK data on file;
  • Brodmann M 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;
  • 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;
  • 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;

The Passeo®-18 Lux® DCB with its Lux® coating is part of the Lux® family of Paclitaxel-coated balloons from BIOTRONIK;

Lux, Passeo and Safeguard are trademarks or registered trademarks of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owne;

Images for illustration purposes only, may not be an exact representation of the device;