Pantera Lux




Clinically proven solution for in-stent restenosis and de novo lesions


Clinical outcomes from multiple studies1-8 including randomized controlled trials like BIOLUX RCT, ISAR-DESIRE 4 and PEBSI show high efficacy and safety for both in-stent restenosis and de novo lesions.







Lux coating technology for rapid drug absorption







Prolonged tissue retention at the target site9, 10

Pig coronary artery Paclitaxel tissue concentrations











Advanced trackability


Pantera Lux, with its low crossing profile, provides advanced trackability to successfully reach and treat most cases in daily practice.


Low crossing profile 11






Low track force11






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

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 atm5 7 7 7 7 7
(NP) ø (mm) 2.00 2.50 3.00 3.50 4.00
Rated Burst Pressure atm5 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


Contact

contact
Country/Region

1 Hehrlein C. et al. Cardiovasc. Revasc. Med. 2012 Sep; 13(5): 260-4;

2 Toelg R. et al. EuroIntervention 2014 Sep; 10(5): 591-9;

3 Naber C.K. EuroPCR 2016. oral presentation. BIOLUX RCT Clinical performance of the Pantera Lux Paclitaxel coated balloon vs. drug-eluting Orsiro hybrid stent system in patients with in-stent restenosis: a randomized controlled trial;

4 Kufner et al. J Am Coll Cardiol Intv 2017;10: 1332 -40, Clinical trials.gov, NCT01632371;

5 Garcia-Touchard et al. EuroIntervention. 2017 Jan 20;12(13):1587-1594. NCT01839890;

6 Vos N. S. et al. Vos N. S. et al. EuroIntervention 2014;10:584-590;

7 Jim M. H. AsiaPCR 2014, oral presentation, Six-month Angiographic Restudy of Paclitaxel-Eluting balloon kissing in Dealing with side branch Ostial Narrowing (SARPEDON);

8 Worthley S. et al. Cardiovasc. Revasc. Med. 2015; 16: 413-417;

9 Radke P. et al. EuroIntervention. 2011 Oct; 7(6): 730-7;

10 BIOTRONIK data on file;

11 BIOTRONIK data on file, compared to main competitors.

SeQuent is a registered trademark of the B. Braun Group of Companies; ELUTAX is a registered trademark of Aachen Resonance; IN.PACT is a registered trademark of the Medtronic Group of Companies; DIOR is a registered trademark of Eurocor.

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