Vascular Intervention //
Coronary
Drug-Coated Balloon Catheter
Pantera® Lux®
Clinically proven. Best in class crossability.
![](https://biotronik.cdn.mediamid.com/cdn_bio_pic/bio27732/38509/bio27732_1.png)
![](https://biotronik.cdn.mediamid.com/cdn_bio_pic/bio28065/38521/bio28065_1.png)
![](https://biotronik.cdn.mediamid.com/cdn_bio_pic/bio28066/38513/bio28066_1.png)
![](https://biotronik.cdn.mediamid.com/cdn_bio_pic/bio28064/38517/bio28064_1.png)
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.
![](https://biotronik.cdn.mediamid.com/cdn_bio_pic/bio28416/38525/bio28416_1.png)
Lux coating technology for rapid drug absorption
![](https://biotronik.cdn.mediamid.com/cdn_bio_pic/bio28411/38529/bio28411_1.png)
Prolonged tissue retention at the target site9, 10
Pig coronary artery Paclitaxel tissue concentrations
![](https://biotronik.cdn.mediamid.com/cdn_bio_pic/bio28412/38533/bio28412_1.png)
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
![](https://biotronik.cdn.mediamid.com/cdn_bio_pic/bio28413/38537/bio28413_1.png)
Low track force11
![](https://biotronik.cdn.mediamid.com/cdn_bio_pic/bio28414/38541/bio28414_1.png)
![](https://biotronik.cdn.mediamid.com/cdn_bio_pic/bio28735/41709/bio28735_1.png)
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
The Pantera® Lux® DCB with its Lux® coating is part of the Lux® family of Paclitaxel-coated balloons from BIOTRONIK.
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).