Pantera® Lux®
PACLITAXEL-RELEASING BALLOON
Indicated for in-stent restenosis, de novo lesions, small vessels and acute occlusions.1 Expand your universe of treatment options with this clinically proven solution. Using the highly biocompatible BTHC excipient, Pantera® Lux® effectively delivers a proven antiproliferative drug to the lesion site – without leaving an implant behind.
KEY FACTS
- Clinically proven solution in both in-stent restenotic and de novo lesions2,3
- Advanced trackability to smoothly reach the lesion site
- Highly biocompatible BTHC excipient for safe results
Product Details
Clinically Proven Solution in Both In-Stent Restenotic and De Novo Lesions
Clinical outcomes from both the PEPPER and DELUX clinical studies with more than 1000 patients show high efficacy and safety for Pantera Lux in both in-stent restenotic and de novo lesions.
Advanced Trackability to Smoothly Reach the Lesion Site
Pantera Lux is based on the Pantera semi-compliant balloon and provides advanced trackability to successfully reach and treat most cases in daily practice.
Highly Biocompatible BTHC Excipient for Safe Results
Pantera Lux coating technology blends paclitaxel with BTHC, a rapidly metabolized, safe and biocompatible excipient4, thus improving bioavailability. Homogeneous balloon coating ensures proper treatment of drug to the entire region touched by the balloon inflation, minimizing geographic miss. Tissue retention: Following one application of the Pantera Lux, paclitaxel can be readily detected in the treated region beyond seven days in animal tissue.
DELUX Registry
- Prospective, multi-center international registry
- Number of patients (n): 1,064
ISAR-DESIRE 4 RCT
- Prospective, randomized, active, controlled multi-center clinical trial to compare the anti-restenotic efficacy of scoring balloon (SCB) pre-dilation before drug-coated balloon (DCB) therapy versus standard balloon pre-dilation (Plain Old Balloon Angioplasty, POBA) before DCB therapy in patients with limus-eluting stent (LES) restenosis. Baseline characteristics were not significantly different in the two groups.
- Number of patients (n): 252
- Primary endpoint: Percent diameter stenosis (%DS) at 6-8 months
PEBSI RCT
- Prospective, multi-center, randomized, investigator-initiated trial to compare the efficacy and safety of the combined treatment of BMS plus DCB versus the conventional treatment (BMS only) in patients with STEMI within 12 hours of symptom onset. Baseline characteristics were similar in both groups
- Number of patients (n): 223
- Primary angiographic endpoint: 9-month late lumen loss (LLL)
PEPPER Registry
- Prospective, multi-center, non-randomized European clinical trial
- Number of patients (n): 81
- Primary endpoint: In-stent late lumen loss (LLL) at 6 months
Technical Data
| Drug-Releasing Balloon | |
|---|---|
| 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) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||||||
Ordering Information
Contact
The Pantera® Lux® DCB with its Lux® coating is part of the Lux® family of Paclitaxel-coated balloons from BIOTRONIK.
Pantera and Lux are trademarks or registered trademarks of the BIOTRONIK Group of Companies.
1 Indications may differ in countries not accepting CE mark.
2 Hehrlein C et al. Cardiovasc Revasc Med. 2012 Sep;13(5):260-4.
3 Toelg R et al. EuroIntervention 2014 Sep;10(5):591-9.
4 Joner et al. Thrombosis and Haemostasis. 2011 May;105(5):864-72.
5 1 atm = 1.013 bar