A First Look at and Interim Analysis of 12 month Outcomes from the

Lutonix Global SFA Registry

A Prospective, Global Multicenter, Single Arm Real-World

Registry Investigating the Clinical Use and Safety of the

Lutonix® Drug Coated PTA Dilatation Catheter

Dr. Michael Lichtenberg Karolinen Hospital, Germany

Conflicts of Interest

Registry Objectives

Demonstrate safety and assess the clinical use and outcomes of the Lutonix DCB in a heterogeneous patient population in real-world clinical practice.

Registry Design

Enrollment • Up to 1000 patients with

femoropopliteal lesions

• Registry to include up to 75 sites

• Follow up 1m, 6m, 12m and 24m by phone or at clinic

• Patient consent for 5 year F/U

Inclusion • Male or non-pregnant female ≥ 18

years

• Rutherford Class ≤ 4

• Stenotic or obstructive vascular lesions of the Fem-Pop artery treated per IFU

• At least one patent native outflow artery to the ankle free from significant lesion (≥ 50% stenosis) as confirmed by angiography

G\Real World Global Registry Status Enrollment ended with 691 patients

• Global, real world, all comer data

• Multi center participation: 38 sites from 11 countries participated in the Registry

• Enrollment: Dec 2012 – Jul 2014

6 13 18

28 28

49

53

59

68

371

Enrollment by country

France Spain Switzerland Poland UK

Belgium Greece Italy Austria Germany

5

Primary End Points

• Freedom from TLR at 12 months Effectiveness

• Freedom at 30 days from • TVR • Major limb amputation • Device or procedure related

death Safety

Baseline Clinical Characteristics

N 691

Age, mean ± SD (n) 68.2 ± 9.8 (687)

Male gender, % (n/N) 67.5% (464/687)

Hypertension, % (n/N)* 85.2% (585/687)

Diabetes Mellitus, % (n/N) 39.6% (272/687)

Dyslipidemia, % (n/N) 70.5% (484/687)

Current Smoker, % (n/N) 36.6% (251/686) History of chronic renal insufficiency,

% (n/N) 10.5 % (72/687)

Rutherford Class Breakup

6.7%

4.4%

17.4%

62.9%

7.3%

1.2%

0.1%

NA

Class 1

Class 2

Class 3

Class 4

Class 5

Class 6

Lesion Characteristics

Target Lesion length (mm), mean ± SD (n)

101.8 ± 84.3 (675)

Total treated length, min - max (mm) 197.3 ± 133.5

(201)

Calcification % (n/N) 34.4% (233/678)

Total Occlusion, % (n/N) 30.8% (208/675) Lesion location

Proximal SFA 7.7% (52/673) Mid SFA 25.3% (170/673)

Distal SFA 37.1% (249/67) Proximal Popliteal 16.9% (114/673)

Mid Popliteal 10.3% (69/673) Distal Popliteal 2.7% (18/673)

Case: Lutonix DCB Final Result Pre-Procedure

Real World 12 Month Outcomes Primary End Points

• Freedom from TLR at 12

months 89.3% • N = 201 @ 12 months

Effectiveness

• Site-Reported Safety

Endpoint 99.3% N = 608 @ 30 days

Safety

Real World Primary Patency 12 month Secondary End Point

12 Month Outcomes Secondary End Points*

All Cause Death 1.8% (4/215)

Device or procedure related death 0.0% (0/211)

Major index limb amputation 0.0% (0/211)

Minor index limb amputation 0.9% (2/213)

Reintervention for treatment of embolization to its distal vasculature

0.9% (2/213)

Reintervention for treatment of thrombosis of the target vessel

0.0% (0/211)

* CEC Adjudicated

Summary at 12 months ↑ Real-World Freedom from TLR 89.3% comparable

to blinded Levant2 trial (89.7%)

↑ Real World Site-Reported primary patency 81%

↑ Reinforced Confidence in Lutonix Safety ↓ Major index limb amputation 0.0%

↓ Re-intervention for treatment of embolization to distal

vasculature 0.9%

↓ Reintervention for treatment of thrombosis of the target vessel 0.0%