Commitment to Safety
Lutonix® considers safety a top
priority and has designed the
Lutonix® 035 to maximize
LEVANT I
CLINICAL TRIAL
efficacy without
sacrificing safety:
Higher Event-Free Probability at 24 Months3
· Safety profile comparable
to PTA as demonstrated in
LEVANT I1 and LEVANT 22
· Proprietary coating and
formulation designed to:
- Minimize systemic paclitaxel
exposure
- Minimize downstream
effects
- Ensure durability during
preparation and handling
LEVANT 2
CLINICAL TRIAL
Freedom from Primary Safety Event
at 365 Days
100%
80%
86.7%
81.5%
60%
Primary Safety Event Summary
12 Months - LEVANT 2
Lutonix® 035
DCB
n (%)
Standard
PTA
n (%)
Distal embolization with study
treatment
1/316
(0.3%)
1/160
(0.6%)
Distal embolization with
post-treatment
0/316
(0.0%)
1/160
(0.6%)
Reintervention for thrombosis
1/285
(0.4%)
1/140
(0.0%)
Major amputation
1/286
(0.3%)
0/140
(0.0%)
· Loss of Patency
· Amputation
· Thrombosis
· Death
Lutonix® 035 was proven to be safe and effective in LEVANT 2, a rigorous,
Level 1, prospective, multi-center, randomized, single-blinded clinical study.
No increase in
primary safety
events:2
· Index Limb Related
Amputation
40%
Primary Patency (KM) at 365 Days
P=0.001
100%
Superior Primary
Patency2 to PTA
at 12 months:
80%
60%
73.5%
56.8%
40%
· Reintervention
20%
0%
No increase in
primary safety
events, including:1
LUTONIX® 035
N=183
Standard PTA
N=88
· Death
20%
0%
LUTONIX® 035
N=264
Standard PTA
N=135
Lutonix® 035 was proven to be non-inferior to PTA in terms of safety2
Bard and Lutonix are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate. Copyright 2014 C. R. Bard, Inc. All rights reserved.
Advancing Lives and the Delivery of Health Care™
· In LEVANT 2,
Lutonix® 035
demonstrated
a 29.4% better
primary patency
rate at 12 months
than PTA
Commitment to Safety
Proprietary Coating and Formulation
Designed to:
Minimize Systemic Paclitaxel Exposure
Minimize Downstream Effects
· Low balloon drug load
· No significant evidence of downstream emboli/
toxicity in an animal model even with 4x dose5, 8
· No detectable drug in plasma at 24 hours5, 8
· Highly soluble excipients6, 8
28 days - no evidence of vascular changes
in downstream muscel in an animal model4
90 days - no evidence of vascular changes in
downstream muscel in an animal model4
Ensure Durability During Preparation
and Handling
· <1% drug flaking after dry inflate bench test6, 7, 8
· Scientifically designed to achieve high drug
retention on the balloon during preparation and
handling
Treatment with the Lutonix® 035 DCB is contraindicated in patients with known hypersensitivity to paclitaxel
or paclitaxel-related compounds, and in patients who cannot receive recommended antiplatelet and/or
anticoagulant therapy.
1
2
3
Safety is defined as freedom from loss of patency, amputation, thrombosis, and death.
LEVANT 2 clinical trial data on file. N=476. At 12 months, treatment with Lutonix® 035 resulted in a primary
patency rate of 73.5% versus 56.8% with PTA alone (p=0.001). Primary patency defined as absence of
binary restenosis defined by DUS PSVR ≥ 2.5 and freedom from Target Lesion Revascularization (TLR).
At 12 months, treatment with Lutonix® 035 resulted in a freedom from primary safety event rate of 86.7%
versus 81.5% with PTA alone. Primary safety defined as composite of freedom from all-cause perioperative
death and freedom at 1 year in the index limb from amputation (ATK or BTK), reintervention, and Index-limb
related death. Percentages repoted are derived from Kaplan-Meier analyses, not pre-specified.
Rosenfield, et. al The LEVANT I (Lutonix® 035 Paclitaxel-Coated Balloon for the Prevention of
Femoropopliteal Restenosis) Trial for Femoropopliteal Revascularization JACC: Cardiovascular Interventions
Vol 7, No. 1, 2014
Advancing Lives and the Delivery of Health Care™
4
5
6
7
8
LEVANT 2 Clinical Trial- Six Month Results. Data on file.
Yazdani, et. al Downstream and Pharmacokinetic Responses to Treatment within a Low Dose Drug- Coated
Balloon in a Swine Femoral Artery Model. Catheter Cardiovasc. Interv. 2014;83(1):132-40
Lutonix® bench test 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.
Bench or pre-clinical data may not be indicative of clinical performance.
Bard and Lutonix are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.
Copyright 2014 C. R. Bard, Inc. All rights reserved.