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Teleflex Acquires Substantially All of BIOTRONIK Vascular Intervention Business

The BIOTRONIK Vascular Intervention business has been acquired by Teleflex, effective as of July 1st, 2025. These products are now part of the Teleflex portfolio.
For questions or further information relating to the Vascular Intervention portfolio, please complete the contact form below.

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Key benefits

  • Clinically proven

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

  • For challenging patient groups

    Excellent results despite a complex population at baseline3

  • Effective drug delivery

    Reduction of drug loss with SafeGuard™ Insertion Aid4

Clinically proven

Head-to-head comparison of Passeo®-18 Lux® DCB to IN.PACT Admiral DCB

bio_rct Table Image

BIOPACT RCT

Passeo-18 Lux DCB has shown non-inferiority to the IN.PACT Admiral DCB at follow-up5,6,7

36-month outcomes

92.5% vs. 93.7%

Freedom from cd-TLR

99.3% vs. 100%

Freedom from major target limb amputations

  • Passeo- 18 Lux
  • IN. PACT Admiral
More information about BIOPACT RCT

Safe and effective in the treatment of peripheral artery disease (PAD) in the femoropopliteal and infrapopliteal arteries4,5

Randomized Control Trial (RCT)

Femoropopliteal artery

70% relative risk reduction in 12-month TLR versus the control PTA balloon1

Randomized Control Trial (RCT)

Infrapopliteal artery

No MAE at 30 days2

One of the largest real-world DCB registries with few exclusion criteria

BIOLUX P-III

All-comers 24-month outcomes confirm Passeo-18 Lux DCB's safety and effectiveness in infra-inguinal arteries3

24-month outcomes

88.1%

Freedom from cd-TLR

96.5%

Freedom from major amputations

More information about BIOLUX P-III

For challenging patients

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
Freedom from
cd-TLR◊ at 24 months(%)
Femoropopliteal3 592 46.6% 22%
Critical limb ischemia8 328 45.0% 68.6%
Below the knee9 151 36.4% 63.6%
Diabetes mellitus10 418 48.3% 40.9%
In-stent restenosis3 103 27.6% 21.2%

Freedom from major target limb amputation at 24 months

90.1%

BTK subgroup

93.9%

CLI subgroup

Watch clinical animation

Effective drug delivery

LUX® COATING

High drug retention coating with hydrophobic BTHC excipient11

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

Insertion and handling

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

Passeo-18 Lux in Action

REACT strategy: Treating Long SFA Occlusions with a Single Long-Length Drug-Coated Balloon (DCB) + Bare-Metal Stent (BMS)

REACT strategy: Treating Long SFA Occlusions with a Single Long-Length Drug-Coated Balloon (DCB) + Bare-Metal Stent (BMS)

Figure 1

Figure 2

Patient history

An 81-year-old woman presented with claudication of the right leg.

Procedure summary

Angiography showed a flush occlusion at the bifurcation between the deep femoral artery (DFA) and superficial femoral artery (SFA). After crossing, control angiography showed a diffuse, sub-occlusive long SFA lesion (Figure 1).

Pre-dilatation was performed with plain angioplasty balloon. Next, one long-length Paclitaxel-coated Passeo-18 Lux DCB (6 x 200 mm) was inflated for three minutes to treat the segment, followed by a Pulsar-18 T3 BMS.

Results

The final angiography showed complete revascularization of the femoropopliteal segment (Figure 2).

Request the full case report here
Drug-Coated Balloon Treatment for Critical Limb Ischemia

Drug-Coated Balloon Treatment for Critical Limb Ischemia

Figure 1

Figure 2

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 (Figure 1).

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 (Figure 2).

Request the full case report here
Improving Potential Long-Term Patency of Common Femoral Artery Stenoses

Improving Potential Long-Term Patency of Common Femoral Artery Stenoses

Figure 1

Figure 2

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 1).

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 2).

Request the full case report here
REACT strategy: DCB + BMS for a Long SFA Occlusion

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

Figure 1

Figure 2

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
Distal Popliteal Access for Low-Profile Stenting and DCB Therapy

Distal Popliteal Access for Low-Profile Stenting and DCB Therapy

Figure 1

Figure 2

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 (Figure 1).

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 (Figure 2).

Request the full case report here

Testimonials

Prof. Marianne Brodmann (Graz, Austria) discusses the types of lesions for which she uses the Passeo-18 Lux DCB.

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  • Scheinert D. PTX 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. PTX-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. PTX-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;
  • Data on file;
  • Deloose K. The head-to-head Passeo-18 Lux vs IN.PACT Admiral BIOPACT RCT: latest release of the 36 month outcomes. Presented at: LINC 2025; January 28-30, 2025; Leipzig, Germany;
  • Deloose KR, Lansink W, Brodmann M, et al. Head-to-Head Comparison of 2 Paclitaxel-Coated Balloons for Femoropopliteal Lesions. JACC: Cardiovascular Interventions 2023;16:2900-14;
  • Data on file;
  • Brodmann M et al. Real-World Experience With a PTX-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;
  • Data on file

The Passeo®-18 Lux® DCB with its Lux® coating is part of the Lux® family of PTX-coated balloon.

Teleflex, the Teleflex logo, and Passeo®-18 Lux® are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative. Revised 09/2025. ©2025 Teleflex Incorporated. All rights reserved. BIOTRONIK is a trademark or registered trademark of BIOTRONIK SE & Co. KG. All rights reserved.

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