Pantera Lux Paclitaxel Releasing BalloonExpand your universe

Vascular Intervention

Drug Releasing Balloons

Pantera Lux

A proven anti-proliferative drugPaclitaxel is a proven antiproliferative drug characterized by fast absorption due to its lipophilic nature and prolonged tissue retention rates. After short exposure, smooth muscle cell proliferation and migration is altered over a period of at least 14 days.1

1 Gray et al. Circulation 2010 June;121:2672-80.

Increased bioavailability for optimal results Bioavailability is the degree to which a medication becomes available at a targeted site. With the Lux technology, the addition of the BTHC (Butyryl-tri-hexyl citrate) excipient disrupts the crystalline structure of paclitaxel into a readily absorbable microcrystalline therapeutic.

Pure paclitaxel crystalline structure

Matrix coating structureallows a quick absorption of the anti-proliferation agent.

Uniformpaclitaxel dose

controlled drug release

Pharmacokinetics show persistent drug effectFollowing one application of the Pantera Lux, paclitaxel can be readily detected in the treated region beyond 7 days in animal tissue.

400

300

200

100

030 minutes

N = 62 hours

N = 68 hours

N = 81 day N = 6

[µg/

g]

3 days N = 6

7 days N = 6

Pig coronary artery paclitaxel tissue concentrations3

BTHC is a highly biocompatible excipientBTHC degrades to citric acid and alcohol, is rapidly metabolized by the body and commonly used in other medical applications. Biocompatibility testingwith the excipient shows safe and low inflammatory results.

Inflammation score – Pre-clinical testing demonstrated the safety of the Pantera Lux2.

The inflammation score shows a low level of inflammatory response after balloon applicationin a pig coronary artery model, at 28 days.

3

2

1

0POBA Pantera Lux Competitor 1 Competitor 2

Scor

e

0.57 0.93 0.85 1.03

2 Joner et al. Thrombosis and Haemostasis. 2011 May;105(5):864-72. 3 Radke P. et al. EuroIntervention. 2011 Oct; 7(6):730-7.

Superiordeliverability A coating technology for consistent resultsThe applied coating technology allows the balloon to have a homogeneous, circumferential matrix coating for increased bioavailability. Extensive testing and quality control ensure that balloons manufactured by BIOTRONIK are coated within tight specifications.

The flexible balloon material guarantees ideal protection during transit for drug areas below the folds.

Platinum-iridium embedded markers provide x-ray visibility and identify the drug coated region.

Lux 3.0/10

How it works in in-stent restenosis

PEPPER is a multicenter clinical trial evaluating the safety and efficacy of the Pantera Lux in 81 patients with ISR6-month in-stent LLL is 0.07 mm in a mixed population of BMS and DES ISR9.2 % TLR and 11.8 % MACE rate (no cardiac death) at 12 months confirm excellent efficacy and safety

Clinical results from the PEPPER trial 4

safe and consistent drug effect

Covering the complete lesion segment, inflation is maintained for at least 30 seconds, releasing the anti proliferative drug.

Pantera Lux is withdrawn as the drug penetrates into the artery wall. Paclitaxel will act over several days to inhibit cell regrowth.

4 Hehrlein C et al. Cardiovasc Revasc Med. 2012 Aug 3. [Epub ahead of print]; Clinicaltrials.gov: NCT00961181

After pre-dilatationwith an uncoated balloon, the Pantera Lux is advanced to the lesion site.

BalloonCatheter type Fast-exchange PTCA balloon catheterLesion entry profile 0.017"Shaft diameter Proximal 2.0F

Distal 2.5F (ø 2.0 - 3.5 mm)2.6F (ø 4.0 mm)

Balloon markers Two embedded platinum-iridium markersBalloon wrapping Tri-foldRecommended guide catheter 5F (min. I.D. 0.056")Guide wire diameter 0.014"Usable catheter length 140 cmShaft markers Brachial 92 cm from tip

Femoral 102 cm from tipNominal Pressure (NP) 7 atmRated Burst Pressure (RBP) 13 atm (ø 2.0 - 3.5 mm)

12 atm (ø 4.0 mm)

CoatingDrug PaclitaxelDrug dose 3.0 µg/mm2 Delivery matrix Paclitaxel and Butyryl-tri-hexyl citrate (BTHC)Coated area Cylindrical and tapered section of the balloon; exceeding the

proximal and distal markers

Technical data

Pressure (atm) Balloon diameter (mm)

2.0 2.5 3.0 3.5 4.06 1.96 2.44 2.92 3.40 3.88

NP 7 2.00 2.50 3.00 3.50 4.008 2.04 2.55 3.08 3.60 4.129 2.09 2.60 3.16 3.70 4.24

10 2.13 2.66 3.24 3.81 4.3511 2.17 2.71 3.32 3.91 4.47

RBP 12 2.22 2.77 3.40 4.01 4.59RBP 13 2.26 2.82 3.48 4.11 4.71

14 2.30 2.87 3.56 4.21 4.8315 2.35 2.93 3.64 4.31 4.9416 2.39 2.98 3.72 4.41 -

Compliance chart

NP: Nominal Pressure RBP: Rated Burst Pressure

Balloon diameter (mm) 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

Product ordering information

Pantera Lux Paclitaxel Releasing BalloonExpand your universe

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© BIOTRONIK AGAll rights reserved. Specifications are subject to modification, revision and improvement.

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