Vascular Intervention //
Coronary
Drug-Coated Balloon Catheter
Pantera® Lux®
Clinically proven. Best in class crossability.




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.



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 |