i n t e r n at i o n a l

RX
Coronary

Science Behind Outcomes™

Uniform Drug Delivery1,3

99% Coating Integrity2,3

Low Dose 2 µg per mm2 Paclitaxel

 SCI ENCE B EH I N D OUTCOM ES™

uniform DRUG DELIVERY

Paclitaxel

In vivo administration of fluorescent-labeled paclitaxel drug coated balloon to the artery

harvested one hour after deployment shows uniform delivery to endoluminal surface.1,3

Uniform, transfer-efficient coating optimizes drug delivery and uptake1,3

• 360° coverage of paclitaxel on the balloon

• Coating applied while balloon is inflated

• <4% segment-to-segment variability in balloon drug load4

99% cOATING INTEGRITY

Scientifically designed to remain on balloon until drug delivers to vessel wall2,3

• <1% drug flaking after dry inflate bench test2,3

low dose 2 µg per mm2 PACLITAXEL

Low dose minimizes downstream and systemic exposure5

• 2 µg per mm2 paclitaxel with polysorbate and sorbitol carriers

- Therapeutic drug delivery with 30-second minimum inflation time

• No significant pre-clinical evidence of downstream emboli/toxicity

in an animal model even with 4x dose5

1. Lutonix pre-clinical animal data on file.
2. Lutonix bench test data on file.
3. Bench or pre-clinical results may not be indicative of clinical performance. Different test methods may yield different results.
4. Lutonix bench test data on file. Based on average results from PTA balloons (sized 4 x 20 mm) tested.
5. Yazdani, S., Virmani, R. Vascular, Downstream and Pharmacokinetic Responses to Treatment with a Low Dose Drug-Coated Balloon
in a Swine Femoral Artery Model. Catheter Cardiovasc Interv. 2014;83(1):132-40.
 COAT I N G I N T EG R I T Y M AT T E R S

comparison of coatings
The Lutonix® coating sheds between 90 to 252 times
less paclitaxel than the competitive balloons tested.6

Lutonix® Competitor 1

Competitor 2 Competitor 3

proven Lutonix COATing

• Safety, effectiveness and anti-restenotic drug benefits demonstrated in
coronary arteries in De Novo Pilot Study7 and PERVIDEO I Registery

• Same drug coating as the Lutonix® 035 and 014 Drug Coated
Balloon PTA Catheters used in European peripheral cases since 2012

.014"
Coronary Lutonix® 014 PTCA
4 x 30

.014"
2 x 80 Lutonix® 014 PTA8

.035"
6 x 100 Lutonix® 035 PTA8

The Lutonix Proven Platform of Drug Coated Balloons

6. Data on file. Quantitative testing with dry inflate/shake method. Balloon catheters were inflated and shaken five times in a 50mL centrifuge tube. The amount of paclitaxel remaining
on the balloon and the amount shed during inflation and shaking were analyzed. Different test methods may yield different results.
7. Gutiérrez-Chico, JL. Paclitaxel-Coated Balloon in Combination with Metal Stent for Treatment of De Novo Coronary Lesions. EuroIntervention. 2011;7:711-722.
8. The Lutonix® 014 PTA and Lutonix® 035 Drug Coated Balloon PTA Catheters are intended for use in the lower extremities. Please consult product labels and package inserts for
indications, contraindications, hazards, warnings, cautions and instructions for use.
 Science Behind Outcomes™

138 cm Shaft Length / .014" Guidewire Compatible / RX 138 cm Shaft Length / .014" Guidewire Compatible / RX
Nominal Nominal
Diameter Length RBP † Guide Product Diameter Length RBP † Guide Product
Pressure* Pressure*
(mm) (mm) (ATM) Catheter Codes (mm) (mm) (ATM) Catheter Codes
(ATM) (ATM)
9 6 14 5F 9020138 150009 9 6 14 5F 9020138 300009
15 6 14 5F 9020138 150015 15 6 14 5F 9020138 300015
1.50 20 6 14 5F 9020138 150020 3.00 20 6 14 5F 9020138 300020
30 6 14 5F 9020138 150030 30 6 14 5F 9020138 300030
40 6 14 5F 9020138 150040 40 6 14 5F 9020138 300040
9 6 14 5F 9020138 200009 9 6 14 5F 9020138 350009
15 6 14 5F 9020138 200015 15 6 14 5F 9020138 350015
2.00 20 6 14 5F 9020138 200020 3.50 20 6 14 5F 9020138 350020
30 6 14 5F 9020138 200030 30 6 14 5F 9020138 350030
40 6 14 5F 9020138 200040 40 6 14 5F 9020138 350040
9 6 14 5F 9020138 225009 15 6 14 5F 9020138 400015
4.00
15 6 14 5F 9020138 225015 30 6 14 5F 9020138 400030
2.25 20 6 14 5F 9020138 225020 15 6 14 6F 9020138 450015
4.50
30 6 14 5F 9020138 225030 30 6 14 6F 9020138 450030
40 6 14 5F 9020138 225040 * Nominal pressure: the pressure at which the balloon reaches its labeled diameter.
9 6 14 5F 9020138 250009 † R BP (Rated Burst Pressure): the pressure at which Bard has 95% confidence that 99.9% of the balloons will not
burst at or below upon single inflation.
15 6 14 5F 9020138 250015
Please contact your local Bard Sales Representative for availability of sizes.
2.50 20 6 14 5F 9020138 250020
30 6 14 5F 9020138 250030
40 6 14 5F 9020138 250040
9 6 14 5F 9020138 275009
15 6 14 5F 9020138 275015
2.75 20 6 14 5F 9020138 275020
30 6 14 5F 9020138 275030
40 6 14 5F 9020138 275040

Lutonix® 014 PTCA Drug Coated Balloon Catheter
Intended Use / Indications for Use The Lutonix® Catheter is intended for use as a PTCA catheter to dilate stenotic
lesions in the coronary vasculature for the purpose of improving myocardial perfusion and decreasing the incidence
of restenosis.
Contraindications
The Lutonix® Catheter is contraindicated for use in:
• Patients with known hypersensitivity to paclitaxel or paclitaxel related compounds.
• Patients who cannot receive recommended anti-platelet and/or anticoagulant therapy.
• Women who are breastfeeding, pregnant, or are intending to become pregnant or men intending to father children.
Warnings
• Contents supplied STERILE using ethylene oxide (EO) process. Do not use if sterile barrier is damaged or opened prior
to intended use.
• Do not use after the “Use By” date. Do not use if product damage is evident.
• The Lutonix® Catheter is for use in one patient only: do not reuse in another patient, reprocess, or resterilize. Risks of
reuse in another patient, reprocessing, or resterilization include:
— Compromising the structural integrity of the device and/or device failure which, in turn, may result in patient injury,
illness or death.
— Creating a risk of device contamination and/or cause patient infection or cross-infection, including, but not limited
to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to
patient injury, illness, or death.
• Do not exceed the Rated Burst Pressure (RBP) recommended for this device. Balloon rupture may occur if the RBP
rating is exceeded. To prevent over-pressurization, use of a pressure monitoring device is recommended.
• Use the recommended balloon inflation medium of contrast and sterile saline (≤ 50% contrast). Never use air or any
gaseous medium to inflate the balloon.
Precautions
• The safety and effectiveness of the Lutonix® Catheter have not been established in pediatric patients and in adult
cerebral, carotid, or renal vasculature.
• Consideration should be given to the risks and benefits of use in patients with a history of non-controllable allergies
to contrast agents.
Potential Adverse Events
Potential adverse events which may be associated with a coronary balloon dilatation procedure include: • Abrupt
vessel closure • Acute myocardial infarction • Access site discomfort, vessel injury, bleeding, infection • Additional
intervention • Arrhythmia, including ventricular fibrillation (VF) • Cardiac tamponade or pericardial effusion
• Cardiogenic shock/pulmonary edema • Coronary artery bypass graft surgery • Coronary artery spasm • Coronary
vessel aneurysm, dissection, perforation, rupture, or injury • Death • Drug reaction, allergic reaction to contrast
media • Embolism • Endocarditis • Heart failure • Hemorrhage or hematoma • Histologic changes in vessel wall,
including inflammation, cellular damage or necrosis • Hypotension/hypertension • Infection/Sepsis • Inflammation
• Myalgia/arthralgia • Myocardial ischemia • Restenosis of the dilated vessel • Total occlusion of the coronary artery
or bypass graft • Stroke • Thrombosis • Unstable angina
Potential adverse events that may be unique to the Lutonix® Catheter paclitaxel drug coating: • Allergic reaction to the
drug coating • There may be other potential adverse events that are unforeseen at this time.

AUSTRIA Bard Medica SA, MGC-Top Nr. D36, 3.OG Ebene, Modecenterstrasse 22, 1030 Wien, Austria Tel: +43 14 949130 Fax: +43 14 94913030
BENELUX Bard Benelux n.v., Hagelberg 2, 2250 Olen, Belgium Tel: +32 14 286950 Fax: +32 14 286966
CZECH REPUBLIC Bard Czech Republic s.r.o., Taborska 619, 140 00, Prague, Czech Republic Tel: +420 242 408630 Fax: +420 242 410185
FRANCE Bard France SAS, Av. Joseph Kessel 164-166, Parkile P14, 78960 Voisins-le-Bretonneux, France Tel: +33 1 39305858 Fax: +33 1 39305859
GERMANY C.R. Bard GmbH, Wachhausstrasse 6, 76227 Karlsruhe, Germany Tel: +49 721 94450 Fax: +49 721 9445111
GREECE Bard Hellas SA, 22, Alkiviadou St & 72, Vouliagmenis Av, 16675 Glyfada, Greece Tel: +30 210 9690770 Fax: +30 210 9628810
ITALY Bard S.p.A., Via Cina 444, 00144 Roma, Italy Tel: +39 06 524931 Fax: +39 06 5295852
Netherlands C.R. Bard Netherlands Sales B.V., Lorentslaan 4, 3401 MX Ijsselstein, The Netherlands Tel: +31 88 01 22 500 Fax: +31 88 01 22 501
IRELAND Bard Ltd, Arena House, Arena Road, Sandyford, Dublin 18, Ireland Tel; +353 121 30706 Fax: +353 121 30604
NORDIC Bard Norden AB, Karbingatan 22, 254 67 Helsingborg, Sweden Tel: +46 42 386000 Fax: +46 42 386010
POLAND Bard Poland sp.z.o.o., ul. Cybernetyki 7B, 02-677 Warsaw, Poland Tel: +48 22 3210930 Fax: +48 22 3210938
SPAIN Bard de Espana S.A.U., Plaza Europe 41-43, 5A Planta (Torre Realia), 08908 L'Hospitalet de Llobregat, Spain Tel: +34 93 2537800 Fax: +34 93 2537834
SWITZERLAND Bard Medica SA, Seestrasse 64, 8942 Oberrieden/Zürich, Switzerland Tel: +41 44 7225360 Fax: +41 44 7225370
UK Bard Limited, Forest House, Tilgate Forest Business Park, Brighton Road, Crawley, West Sussex RH11 9BP, UK Tel: +44 1293 527888 Fax: +44 1293 552428

Please consult product labels and package inserts for additional information, including device
handling, precautions and instructions for use.
Not available for sale in the USA.
Bard, Lutonix and Science Behind Outcomes are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. Lutonix, Inc., a subsidiary of C. R. Bard, Inc.
Copyright © 2014, C. R. Bard, Inc. All Rights Reserved. 9409 Science Center Drive • New Hope, MN 55428 USA
CM0107-01 Tel: 1 763 445 2352 Fax: 1 763 445 2353 1434