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.
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