1. Novolimus Elution from a Biodegradable Polymer Coated Coronary Stent
EXCELLA
DESyne BD
Novolimus Elution from a Biodegradable Polymer Coated Coronary Stent
Stefan Verheye, MD, PhD
DESyne BD is CE mark approved, not available for sale in the US

2. I/we have no real or apparent conflicts of interest to report.
Stefan Verheye, MD, PhD
I/we have no real or apparent conflicts of interest to report.

3. Innovating Vascular Restoration
Broad Product Portfolio

4. Novolimus: excellent performance, known safety profile
Active metabolite of Sirolimus
Binds to FKBP12 forming an immunosuppressive complex
mTOR inhibitor
Known Safety Profile
Patients treated with Sirolimus orally or via DES implantation exposed to significant amount of Novolimus
Potent anti-proliferative
Inhibition of proliferation of hSMC IC50 = 0.5nM
Sustained performance with low drug dose
5 ug/mm stent length for all product platforms
Excellent clinical outcomes

5. A next generation Co-Cr stent platform for DESyne® BD
Platform features
Cobalt chromium alloy stent with low strut thickness for high flexibility and deliverability
Formula XTM coating technology with ultra thin polymer matrix without a primer layer
Novolimus drug dose of 5 mcg per mm of stent length
DESyne BD platform
Cypher
Xience / Promus
Resolute
BioMatrix
Synergy
Strut Thickness (µm)
Polymer Thickness (µm)
Drug Load (µg)
Comparison to other leading DES*
*Data on file at Elixir Medical

6. DESyne BD leaves no polymer behind
Ultra-thin conformal coating with minimal polymer load
Biocompatible byproducts
Sustained Novolimus release from stent, distributed uniformly in vessel
Low particulates
Leaves behind true metallic strut
CE Mark approved

7. EXCELLA BD Randomized Clinical Trial
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RANDOMIZED (3:1), SINGLE BLIND, MULTI-CENTER CLINICAL TRIAL
Co-Principal Investigators:
A. Abizaid and S.Verheye
Angiographic Core Lab: CRC
IVUS Core Lab: Stanford University
CEC/DSMB: CRC
Data Management: CRC
Single/Multiple De Novo Native Coronary Artery Lesions (A-B2)
Vessel Diameters: mm
Stent Diameters: mm
Lesion Length: ≤24 mm
Stent Lengths: mm
Pre-Dilatation required / Post-Dilatation at physicians discretion 7
Cobalt Alloy Stent + Bioabsorbable Polymer + 5µg per mm Stent Length
ENDEAVOR DES Control
n= 31
Geography: Belgium, Germany and Brazil
DESyne BD DES
n= 115
Clinical Follow-up
Angiographic/IVUS (Subset) Follow-up
30d mo mo mo yrs
Clinical Follow-up
Primary Endpoint: In-Stent Late Lumen Loss at 6 months (QCA)
(non inferiority)
Device and Procedure (Clinical) Success
Device-oriented composite endpoint (Death, MI, or TLR)
Key Secondary Endpoints: at 1, 6, 9, 12mo and 2-5 yrs
Clinically driven TLR, TVR and TVF at 1, 6, 9, 12mo and 2-5 yrs
Stent thrombosis rates at 1, 6, 9, 12mo and 2-5yrs ABR, LLL and % volume obstruction at 6 months
Anti-Platelet Therapy for 12 months

8. Baseline Patient Characteristics
DESyne BD
(N=115 patients)
Endeavor
(N=31 patients)
Age, years (± SD)
65.0±9.3
60.4±10*
Male
63.5%
77.4%
Diabetes mellitus
28.7%
25.8%
Current Smoker
18.3%
29.0%
Hypercholesterolemia
72.2%
80.7%
Hypertension
80.9%
Previous myocardial infarction
25.2%
32.3%
Previous CABG
5.2%
0.0%
Previous PCI
20.0%
Unstable angina
10.4%
9.7%
*p = 0.028; all others p=ns

9. Baseline Lesion Characteristics
DESyne BD
(N=127 lesions)
Endeavor
(N=38 lesions)
Target Vessel
Left anterior descending
43.3%
39.5%
Left Circumflex
27.6%
21.1%
Right coronary artery
29.1%
AHA/ACC Lesion class C
16.5%
Lesion Length, mm (± SD)
14.59±5.53
15.30±5.29
Reference Vessel, mm (± SD)
2.94±0.38
3.01±0.46
Ostial Lesion
3.1%
2.6%
Moderate to Heavy Calcification
34.6%
36.8%
Thrombus
0.8% 0%
Bifurcation
7.9%
5.5%
p=ns for all characteristics

10. Angiographic Results 6 months
In-Stent Analysis
DESyne BD
Endeavor
P value
RVD. mm
N(L)=119
N(L)= 38
Post-procedure
3.00±0.37
3.08±0.35
0.31
At 6-months
2.95±0.37
2.99±0.38
0.67
MLD / Late Lumen loss (LLL), (mm)
Acute gain
1.87±0.42
2.01±0.43
0.09
MLD post-procedure
2.76±0.37
2.90±0.34
0.04
MLD at 6-months
2.64±0.39
2.22±0.53
<0.001
LLL at 6-months (in-stent)
0.12±0.15
0.67±0.47
< 0.001
Diameter Stenosis (%)
8.5±44
6.2±4.5
0.002
11.0±6.6
25.6±15.1
Binary Restenosis (%) (in-stent)
0.0%
7.9%
0.003
Volumetric Analysis
N(L)=35
N(L)=16
%Neointimal volume obstruction (%)
3.6±4.2
20.7±14.2
< 0.001 

11. Zone of non-inferiority Pre-specified margin=0.20mm
Primary Endpoint Analysis
6-month In-Stent Late Lumen Loss
Novolimus
0.12
Zotarolimus
0.67
DELTA*
(Upper 1-sided 95% CI)
-0.55 (-0.44)
Non-inferiority
P value
<0.001
Superiority
*Least square means
Zone of non-inferiority
Pre-specified margin=0.20mm
Zone of Superiority
Zone of non-inferiority
Zone of inferiority
Superior
-0.20
-0.20
-0.10
-0.10
0.30
-0.60
-0.60
-0.50
-0.50
-0.40
-0.40
-0.30
-0.30
0.00
0.00
0.10
0.10
0.20
0.40
Upper one-sided 95% CI
Met Primary Non-Inferiority Endpoint and Superiority Endpoint

12. Clinical Results –12 months
0 to 360 days, % (n)
DESyne BD (N=112)*
Endeavor
(N= 31)
P-Value
HIERARCHICAL EVENTS
DEVICE-ORIENTATED COMPOSITE
2.7%
3.2%
1.00
CARDIAC DEATH
0.0% --
TARGET VESSEL MI
0.9%§
CLINICALLY-INDICATED TLR
1.8%
0.52
Definite/Probable Stent Thrombosis
§2 vessel intervention with peri-procedural enzyme rise and no further complications
*Modified Intention to Treat (patients who received a study stent)

13. Conclusions
The EXCELLA BD Trial demonstrated both non-inferiority and superiority of the DESyne BD Novolimus Eluting Stent compared to the control for the primary endpoint of in-stent late lumen loss at 6 months
Angiographic binary restenosis for the DESyne BD stent was significantly lower compared to the control (0.0% vs. 7.9%, p=0.003)
The composite endpoint of cardiac death, TV-MI and CI-TLR remains low and unchanged from 6 months for both groups demonstrating clinical safety of the DESyne BD stent
There were no reported stent thrombosis through 12 months
DESyne BD is CE mark approved, not available for sale in the US