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Europe, Middle East, Africa / Product Areas / Interventional Cardiology/Radiology / Coronary Interventions / Pantera Lux

Pantera™ Lux™ DCB

Clinically proven. Best in class crossability.14

Pantera™ Lux™ Coronary Drug-Coated Balloon (DCB) is indicated for balloon dilation for in-stent restenosis, de novo lesions, acute or impending vascular occlusion and treatment of small vessel disease.a

Pantera Lux product image

Product Highlights

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Clinically proven solution

For in-stent-restenosis and further indications1-12

Coating icon

Lux™ coating technology

For rapid drug absorption13

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Excellent deliverability

Lowest crossing profile for better push and easier cross14

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Clinically proven solution

Clinical outcomes from multiple studies including randomized controlled trials like BIOLUX RCT, ISARDESIRE 4 and PEBSI show high efficacy and safety for both in-stent restenosis and de novo lesions.1-12

More than 3,900 patients treated in clinical studies 1-12,15-16

Pantera™ Lux™ DCB has proven efficacy and safety in multiple clinical trials investigating coronary drug-coated balloons for various implant-free treatment options.1-10

Stent restenosis

Target Lesion Failure (TLF) rate
at 18 months (p>0.99)

TLF Rate

BIOLUX RCT (n=229) 4

DCB is confirmed as a viable treatment option for ISR with the advantage of avoiding an additional stent layer.

REVELATION (n=120) 8

The treatment with Pantera™ Lux™ DCB may represent a valuable alternative strategy in selected STEMI patients undergoing primary PCI.

Mean Fractional Flow Reserve (FFR) rate at 9 months (p=0.27)

TLF Rate Revealation
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Lux™ coating technology for rapid drug absorption

The Lux™ coating technology blends paclitaxel with BTHC, a rapidly metabolized, safe and biocompatible excipient, thus improving bioavailability at the target site.13

Prolonged tissue retention at the target site

Following one application of the Pantera™ Lux™ DCB, paclitaxel can be readily detected in the treated region beyond 7 days in animal tissue.13,14

Pantera Lux Coating Technology
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Excellent deliverability

Pantera™ Lux™ DCB, with its lowest crossing profile, provides better pushability and easier crossability.14

Lowest crossing profile14

Pantera™ Lux™ DCB has a 44% smaller crossing profile.

Pantera Lux Crossing Profile
Pantera Lux Better Pushability

Better pushability 14

136% more force transmitted from hub to distal tip.

Best in class crossability 14

82% less force needed to cross lesions.

Pantera Lux Crossability

Clinical Highlights

BIOLUX RCT4

DCB is confirmed as a viable treatment option for ISR with the advantage of avoiding an additional stent layer

Prospective, multi-center, randomized, controlled clinical trial

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REVELATION8

Excellent and comparable clinical outcome between the DCB and DES groups

24-month follow-up results from the Revelation trial comparing Pantera™ Lux™ DCB vs. 2nd generation DES in patients with Acute Myocardial Infarction

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SCAAR16

Numerically lowest cumulative rate of clinically driven restenosisd

Long term outcome after treatment of de novo coronary artery lesions using three different drug-coated balloons

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Product Overview


Drug-coated balloon catheter
Catheter type Fast-exchange PTCA balloon catheter
Recommended guide catheter 5F (min. I.D. 0.056”)
Lesion entry profile 0.017”
Guide wire diameter 0.014”
Usable catheter length 140 cm
Balloon folding 3-fold
Balloon markers Two embedded platinum-iridium markers
Brachial shaft marker 92 cm from tip
Femoral shaft marker 102 cm from tip
Proximal shaft diameter 2.0F
Distal shaft diameter 2.5F (ø 2.0 - 3.5 mm), 2.6F (ø 4.0 mm)
Nominal Pressure (NP) 7 atm
Rated Burst Pressure (RBP) 13 atm (ø 2.0 - 3.5 mm); 12 atm (ø 4.0 mm)

Coating
Drug Paclitaxel
Drug dose 3.0 μg/mm2
Coating matrix Lux™ coating comprising Paclitaxel and Butyryl-tri-hexyl citrate (BTHC)
Coated area Cylindrical section of the balloon, exceeding the proximal and distal markers

Balloon diameter x length (mm)
ø 2.0 x 10-30 ø 2.5 x 10-30 ø 3.0 x 10-30 ø 3.5 x 10-30 ø 4.0 x 10-30
Nominal Pressure

(NP)		 atm* 7 7 7 7 7
ø (mm) 2.00 2.50 3.00 3.50 4.00
Rated Burst Pressure

(RBP)		 atm* 13 13 13 13 12
ø (mm) 2.26 2.82 3.48 4.11 4.59
*1 atm= 1.013 bar

Balloon Catheter length 140 cm
ø (mm) Balloon length (mm)
10 15 20 25 30
2.00 365110 365111 365112 365113 365114
2.50 365120 365121 365122 365123 365124
3.00 365125 365126 365127 365128 365129
3.50 365130 365131 365132 365133 365134
4.00 365135 365136 365137 365138 365139

IFU Link

Refer to this IFU link for a copy of the Instructions for Use and for a complete listing of the indications, contraindications, warnings and precautions.

References:

The Pantera Lux DCB with its Lux coating is part of the Lux family of Paclitaxel-coated balloons from Teleflex.

  1. Indications as per IFU, it may differ in countries not accepting CE mark
  2. Orsiro
  3. Orsiro or Xience
  4. Compared to SeQuent and IN.PACT Falcon.

  1. Tölg R et al. Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry EuroIntervention. 2014; 10(5). 591-599
  2. Hehrlein C et al. Twelvemonth results of a Paclitaxel Releasing Balloon in Patients Presenting with In-stent Restenosis First-in-Man (PEPPER) trial. Cardiovascular Revascularization Medicine. 2012; 13 (5): 260-264
  3. Kufner S, Joner M, Schneider S et al. Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents. JACC Cardiovasc Interv. 2017; 10(13). 1332 -1340
  4. Jensen C et al. Angiographic and clinical performance of a paclitaxel-coated balloon compared to a second-generation sirolimuseluting stent in patients with in-stent restenosis: the BIOLUX randomised controlled trial. EuroIntervention. 2018; 14: 1096-1103
  5. Nguyen V.P.T et al. Comparison of clinical outcomes of two different types of paclitaxel-coated balloons for treatment of patients with coronary in-stent restenosis. Heart and Vessels. 2019. 1-9. doi: 10.1007/ s00380-019-01388
  6. Assadi-Schmidt A et al. SeQuent Please vs. Pantera Lux drug coated balloon angioplasty in real life: Results from the Düsseldorf DCB registry, Int J Cardiol. 2016. doi: 10.1016/j.ijcard.2016.12.022
  7. Vos NS et al. Safety and feasibility of a Paclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one year clinical outcome of a pilot study. EuroIntervention. 2014; 10(5). 584 -590
  8. Vos N S et al. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction (The REVELATION Randomized Trial). JACC: Cardiovascular Interventions. 2019; 1-9, doi:10.1016/j.jcin.2019.04.016
  9. Worthley S, Hendriks R, Worthley M et al. Paclitaxel-eluting balloon and everolimus-eluting stent for provisional stenting of coronary bifurcations: 12-months results of the multicenter BIOLUX-I study. Cardiovasc Revasc. Med. 2015; 16(7). 413 -417
  10. Jim MH et al. Six month angiographic result of supplementary paclitaxel-eluting balloon deployment to treat side branch ostium narrowing (SARPEDON). Int J Cardiol. 2015; 187:594 -597
  11. Roncalli J et al. Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial). J INVASIVE CARDIOL. 2019;31(4):94-100
  12. García-Touchard A, Goicolea J, Sabaté M et al. A randomised trial of paclitaxel-eluting balloon after bare metal stent implantation vs. bare metal stent in ST-elevation myocardial infarction (the PEBSI study). EuroIntervention. 2017; 12(13). 1587 -1594
  13. Radke P W et al. Vascular effects of paclitaxel following drug-eluting balloon angioplasty in a porcine coronary model: the importance of excipients. EuroIntervention. 2011; 7 (6): 730-737.pdf
  14. Data on file
  15. Galli S et al. Results of paclitaxel-drug-coated balloons (Pantera Lux) for coronary in-stent restenosis: Italian experience from REGistry of Paclitaxel Eluting Balloon in ISR study. Italian Federation of Cardiology. 2021. doi:10.2459/JCM.0000000000001127
  16. Venetsanos D, Omerovic E, Sarno G et al. Long term outcome after treatment of de novo coronary artery lesions using three different drug coated balloons. International Journal of Cardiology. 2020; 1-7. doi: 10.1016/j.ijcard.2020.09.054
Teleflex, the Teleflex logo, Lux and Pantera are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S and/or other countries. All other names are the trademarks or registered trademarks of their respective owners. Refer to this IFU link for a copy of the Instructions for Use and for a complete listing of the indications, contraindications, warnings and precautions. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries. © 2025 Teleflex Incorporated. All rights reserved.