WASHINGTON, D.C.—Use of the MOXY paclitaxel-eluting balloon to treat stenosis of the femoropopliteal arteries beats the use of standard percutaneous transluminal angioplasty (PTA), proving a reduction in clinical events and a shorter duration of antiplatelet therapy, according to Dierk Scheinert, MD, of Herzzentrum Leipzig, in Leipzig, Germany, who presented results of the LEVANT I trial today at the 2010 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting. http://www.cardiovascularbusiness.com/topics/vascular-endovascular/tct-levant-i-trial-shows-promise-drug-eluting-balloons-fem-pop

1. 6-MONTH RESULTS OF THE
LEVANT I TRIAL
A Comparison of the
Moxy™ Drug Coated Balloon Catheter vs.
Standard PTA for Femoropopliteal Disease
NCT# 00930813
Dierk Scheinert, Principal Investigator
on behalf of the LEVANT I Investigators
Heart Center Leipzig/Park Hospital, Leipzig Germany

2. TECHNOLOGY OVERVIEW
• Proprietary 2 g/mm2
paclitaxel coating with
hydrophilic non-polymeric
carrier
• Formulation balances
drug retention during
transit and uptake upon
Lutonix inflation
Paclitaxel Arterial
Optimized
Formulation • Drug delivered during
Tissue Levels
single 30 second inflation
No Sub-Optimal
Carrier Carrier • Robust, uniform coating
Rate of Coating Release
CAUTION: Investigational Device – Limited by Federal (USA) Law to Investigational Use

3. LEVANT I STUDY SUMMARY
A Prospective, Multicenter, Single
Blind, Randomized, Controlled Trial Comparing the
DESIGN Moxy™ Catheter
vs. Standard Balloon Angioplasty for Treatment of
Femoropopliteal Arteries With and Without Stenting
Assess the safety and efficacy of the Moxy™ Catheter
OBJECTIVE for treatment of stenosis of the femoropopliteal arteries
by direct comparison to standard PTA
PRIMARY
Late Lumen Loss at 6 Months
ENDPOINT
MAJOR
TLR, TVR, Primary Patency, Safety
SECONDARY

4. LEVANT I TRIAL STUDY DESIGN
PROTOCOL DEFINED
PRE-DILATION
N=101
BALLOON STENT
GROUP GROUP
N=75 N=26
1:1 1:1
MOXY PTA MOXY PTA
N=37 N=38 N=12 N=14

5. LEVANT I 6-MONTH RESULTS OVERVIEW
Primary endpoint
Late Lumen Loss objective was met.
• ITT Analysis: 0.46 mm (Moxy) vs 1.09 (PTA) p=0.016
• PP Analysis: 0.36 mm (Moxy) vs 1.08 (PTA) p=0.016
Secondary Endpoint
Target lesion revascularization
• ITT Analysis: 13% (Moxy) vs. 22% (PTA)
• PP Analysis: 6% (Moxy) vs. 21% (PTA)
1 month (no stent) and 3 month (stent) clopidogrel regimen
•no reported incidents of acute or late thrombosis in Moxy group

6. LEVANT I LATE LUMEN LOSS AT 6 MONTHS
ITT ANALYSIS
2
P=0.016
Balloon Group Stent Group
N=24
N=35
mm
N=11
N=39 1.09 N=31
1.19 N=8
0.9
0.46 0.45 0.49
0
MOXY PTA MOXY PTA MOXY PTA

7. LEVANT I CONCLUSIONS
*ACHIEVED PRIMARY
1. Strong biologic effect demonstrated on ENDPOINT OF IMPROVED
the inhibition of neointimal hyperplasia. LATE LUMEN LOSS
2. Data suggests the Moxy DCB is safe with a marked decrease
in clinical events compared to PTA
3. Shorter duration anti-platelet therapy appears feasible in the
peripheral vasculature.
4. Large pivotal trial is warranted to further confirm the benefit
of treating SFA-popliteal lesions with a drug-coated balloon.

8. LEVANT II TRIAL: STUDY SUMMARY
DESIGN Prospective, Randomized, Multicenter, Single Blind
Assess the safety and efficacy of the Moxy Catheter for
OBJECTIVE treatment of stenosis of the femoropopliteal arteries by
direct comparison to standard PTA
Safety: Composite of freedom from all-cause
PRIMARY perioperative and 1 year index limb amputation, index
ENDPOINT limb re-intervention, and index-limb-related death.
Efficacy: Primary Patency of the target lesion at 1 year.
FOLLOW-UP To 5 years
PRINCIPAL Kenneth Rosenfield, MD, Boston
INVESTIGATORS Dierk Scheinert MD, Leipzig
EXPECTED START Dec 2010 (IDE pending)