1. EXCELLA Studies - Novolimus Elution from PLLA Polymer Coated Stents DESyne® and DESyne BD: Design Specifications and Clinical Updates
Stefan Verheye, MD, PhD ZNA Middelheim
Antwerp, Belgium
On behalf of the EXCELLA investigators
DESyne and DESyne BD are CE Mark Approved; Not available for sale in the U.S.

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Grant/Research Support
Consulting Fees/Honoraria
Major Stock Shareholder/Equity
Royalty Income
Ownership/Founder
Intellectual Property Rights
Other Financial Benefit
Company Names
Elixir Medical

3. FORMULA coating technology
DESyne® and DESyne® BD
CE Mark-approved Polymer-Coated Workhorse DES
Unique drug agent Novolimus
Potent anti-proliferative with known safety profile
Achieves sustained performance with the lowest drug dose (5 µcg / mm) among DES on the market
Advanced Co-Cr stent platform
Low profile design with ultra-thin (81 µm) struts for high flexibility and deliverability
Optimal vessel wall coverage for uniform drug delivery
Open cell design for ease of side branch access
FORMULA coating technology
Ultra-thin durable or biodegradable polymer and drug matrix coating
No primer coating
Lowest polymer load (<3 µm) for improved biocompatibility*
Biodegradable polymer degrades into biocompatible byproducts leaving behind a true metallic stent
* As reported by manufacturer

4. Co-Cr Stent Platform - DESyne and DESyne BD
Cobalt chromium alloy stent with low strut thickness for high flexibility and deliverability
Formula TM coating technology with ultra thin polymer matrix
Platform features
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

5. EXCELLA II Randomized Clinical Trial Design
RANDOMIZED (2:1), SINGLE BLIND, MULTI-CENTER CLINICAL TRIAL
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
Cobalt Alloy Stent + Durable Polymer + 5µg per mm Stent Length
ENDEAVOR Control
n= 71
Geography: New Zealand, Australia, Europe and Brazil
DESyne
n= 139
30d mo mo mo yrs
Clinical Follow-up
Angiographic/IVUS (Subset) Follow-up
Primary Endpoint: In-Stent Late Lumen Loss at 6 months (QCA)
non-inferiority and superiority)
Device and Procedure (Clinical) Success
Key Secondary Endpoints: Device-oriented composite endpoint (Death, MI, or TLR)
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
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6. Angiographic and IVUS Result at 9 months
In-Stent Analysis
DESyne
NL= 154
Endeavor
NL= 75
P value
RVD Post-procedure (mm)
2.84±0.43
2.91±0.38
0.20
RVD At 9-months (mm)
2.82±0.44
2.70±0.42
0.06
MLD post-procedure (mm)
2.48±0.39
2.57±0.37
0.10
MLD at 9-months (mm)
2.36±0.48
1.95±0.48
< 0.001
DS (%) Post-procedure
12±5
11±5
0.34
DS (%) at 9-months
16±12
28±14
LLL at 9-months
0.11±0.32
0.63±0.42
Binary Restenosis (%)
1.4% (2/138)
7.6%
(5/66)
0.037
Serial IVUS Analysis
DESyne: NL = 34 Endeavor: NL = 15 %
P = <0.001
Endeavor
DESyne
NL = Number of lesions

7. Primary Endpoint Analysis 9-month In-Stent Late Lumen Loss
Novolimus
Eluting DES
0.11
Zotarolimus
0.63
DELTA*
(Upper 1-sided 95% CI)
-0.54 (-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
-0.60
-0.50
-0.40
-0.30
-0.20
-0.10
0.00
0.10
0.20
0.30
0.40
Upper one-sided 95% CI
Met Primary (Non-Inferiority) Endpoint and Superiority Endpoint

8. EXCELLA II 5-year Results

9. Conclusions
The EXCELLA II Trial demonstrated both non-inferiority and superiority of the DESyne Novolimus eluting stent compared to the control Endeavor Zotarolimus eluting stent for the primary endpoint of in-stent late lumen loss at 9-months
Compared to the control, the DESyne Stent demonstrated significantly greater inhibition of neointimal hyperplasia measured by IVUS at 9 months
At 5 years, Target Lesion Revascularization rates were significantly lower in favour of the DESyne Stent (p=0.05)
Device-oriented composite endpoints through 5 years were statistically lower for DESyne (p=0.01)
All components of DoCE (cardiac death, MI and TLR) favoured the DESyne stent; stent thrombosis rates were similarly low in both arms
In this study, the DESyne stent demonstrated superior neointimal inhibition while maintaining an excellent safety profile through 5 years

10. EXCELLA II BD Randomized Clinical Trial Design
RANDOMIZED (3:1), SINGLE BLIND, MULTI-CENTER CLINICAL TRIAL
Single/Multiple De Novo Native Coronary Artery Lesions (A-B2)
Pre-Dilatation required / Post-Dilatation at physicians discretion
Vessel Diameters: mm
Stent Diameters:
Lesion Length:
≤24 mm
Stent Lengths: mm
Cobalt Alloy Stent + Bioabsorbable Polymer + 5µg per mm Stent Length
DESyne BD
n= 115
Geography: Belgium, Germany and Brazil
ENDEAVOR Control
n= 31
Clinical Follow-up
Angiographic/IVUS (Subset) Follow-up
30d mo mo mo yrs
Primary Endpoint: In-Stent Late Lumen Loss at 6 months (QCA)
non-inferiority and superiority)
Device and Procedure (Clinical) Success
Key Secondary Endpoints: Device-oriented composite endpoint (Death, MI, or TLR)
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
Clinical Follow-up
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11. 6-month Serial QCA and IVUS Results
In stent
QCA Analysis
DESyne BD
(NL = 119)
Endeavor
(NL = 38)
P value
RVD (mm)
Post Procedure
3.00±0.37
3.08±0.35
0.31
6 months
2.95±0.37
2.99±0.38
0.67
MLD (mm)
2.76±0.37
2.90±0.34
0.04
2.64±0.39
2.22±0.53
<0.001
Acute gain (mm)
1.87±0.42
2.01±0.43
0.09
Late lumen Loss (mm)
0.12±0.15
0.67±0.47
< 0.001
Diameter Stenosis
Post procedure
8.5±44
6.2±4.5
0.002
11.0±6.6
25.6±15.1
Binary Restenosis (%)
0.0%
7.9%
0.003
Serial IVUS Analysis
DESyne BD: NL = 35 Endeavor: NL = 16 %
NL : Number of lesions

12. Primary Endpoint Analysis
Met Primary Non-inferiority Endpoint and Superiority Endpoint

13. DESyne BD 5-year Results
Cumulative incidence of events (%)
DoCE
Log-Rank p= 0.771
Cardiac Death
Log-Rank p=
TV-MI
Log-Rank p= 0.599
CI-TLR
Log-Rank p= 0.264
Elixir
Endeavor

14. Conclusions
In the EXCELLA II and EXCELLA BD trials both non-inferiority and superiority were demonstrated by the DESyne durable polymer or the DESyne BD biodegradable polymer DES as compared to the Endeavor control DES for the primary endpoint of in-stent late lumen loss at either 6 or 9 months
Clinical events remained low through the final 5-year clinical follow-up demonstrating long-term clinical safety and effectiveness
Clinically-indicated target lesion revascularization rates were markedly lower for both DESyne and DESyne BD as compared to the Endeavor stent through 5 years
In these studies, both DESyne and DESyne BD demonstrated superior neointimal inhibition while maintaining excellent safety profiles through 5 years

15. Backup

16. Baseline Characteristics
Patient Characteristics,
% unless stated
DESyne
(N=139 )
Endeavor
(N=71)
Age, years (± SD)
64.7±9.6
62.7±9.7
Male
76.3%
78.9%
Diabetes mellitus
23.7%
23.9%
Current Smoker
15.9%
22.5%
Hypercholesterolemia
85.5%
76.1%
Hypertension
71.8%
Previous myocardial infarction
26.6%
31.0%
Previous PCI
33.8%
35.2%
Unstable angina
25.2%
Lesion Characteristics (QCA)
(mean ± SD), or %
(NL=156 )
(NL=76)
AHA/ACC Lesion class B2-C
53.8%
50.7%
Reference Vessel, mm (±SD)
2.74±0.48
2.74±0.47
Lesion Length, mm (± SD)
11.1±5.6
12.3±6.5
N= Number of patients
NL = Number of lesions
p = ns for all listed characteristics

17. Baseline Characteristics
Patient Characteristics,
% unless stated
DESyne BD
(N = 115)
Endeavor
(N = 31)
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 PCI
20.0%
Unstable angina
10.4%
9.7%
Lesion Characteristics (QCA)
(mean ± SD), or %
(NL=127)
(NL=38)
AHA/ACC Lesion class B2-C
74.1%
78.9%
Reference Vessel, mm (±SD)
2.94±0.38
3.01±0.46
Lesion Length, mm (± SD)
14.6±5.5
15.3±5.3