Pantera Lux

Vascular Intervention // Coronary
Drug-Coated Balloon Catheter

Pantera® Lux®
Clinically proven. Best in class crossability.


Clinically proven solution for in-stent-restenosis and further indications

Lux® coating technology for rapid drug absorption

Excellent deliverability







Clinically proven solution for in-stent-restenosis and further indications1-12


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











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.14



Prolonged tissue retention at the target site14, 15

Pig coronary artery Paclitaxel tissue concentrations











Excellent deliverability


Pantera Lux, with its lowest crossing profile, provides better pushability and easier crossability.16


Lowest crossing profile16

Pantera Lux has a 44% smaller crossing profile.






Better pushability16

136% more force transmitted from hub to distal tip.






Best in class crossability16

82% less force needed to cross lesions.











Pantera® Lux®
Indicated for balloon dilatation for in-stent restenosis, de-novo lesions, acute or impending vascular occlusion and treatment of small vessel disease.*



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. Twelve-month 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 sirolimus-eluting 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 Dusseldorf 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. Garcia-Touchard A, Goicolea J, Sabate 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. 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; 14. Radke PW et al. Vascular effects of paclitaxel following drug-eluting balloon angioplasty in a porcine coronary model: the importance of excipients. EuroIntervention. 2011 Oct; 7(6): 730-7; 15. BIOTRONIK data on file; 16. BIOTRONIK data on file. Pantera and Lux are trademarks or registered trademarks of the BIOTRONIK Group of Companies. Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies. SeQuent is a trademark or registered trademark of the B. Braun Group of Companies; IN.PACT and FALCON are trademarks or registered trademarks of the Medtronic Group of Companies; MagicTouch is a trademark of Concept Medical or its affiliates; Agent is a trademark or registered trademark of the Boston Scientific Group of Companies; RESTORE is a trademark of Cardionovum; Xience is a trademark or registered trademark of the Abbott Group of Companies.

*Indication as per IFU (may differ in countries not accepting CE mark).

Technical Data

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
Ballon markers Two embedded platinum-iridium markers
Brachial shaft marker 92 cm from tip
Femoral shaft marker
102 cm from tip
Proximal shaft diameter
2.0 F
Distal shaft diameter 2.5 F (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
Delivery 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
10-30
ø 2.5 x
10-30
ø 3.0 ×
10-30
ø 3.5 ×
10-30
ø 4.0 ×
10-30
Nominal Pressure atm** 7 7 7 7 7
(NP) ø (mm) 2.00 2.50 3.00 3.50 4.00
Rated Burst Pressure atm** 13 13 13 13 12
(RBP) ø (mm) 2.26 2.82 3.48 4.11 4.59
                **1 atm = 1.013 bar

Ordering Information


Balloon
ø (mm)
Catheter length 140cm
Balloon length (mm)
10 15 20 25 30
2.0 365110 365111 365112 365113 365114
2.5 365120 365121 365122 365123 365124
3.0 365125 365126 365127 365128 365129
3.5 365130 365131 365132 365133 365134
4.0 365135 365136 365137 365138 365139

Contact

contact
Country/Region