1. 6-Month Imaging and 1 year Clinical and MSCT Results
Multi-Center, First-In-Man (FIM) Evaluation of the Myolimus-Eluting Bioresorbable Coronary Scaffold:
6-Month Imaging and 1 year Clinical and MSCT Results
Stefan Verheye1, Mark Webster2, Jim Stewart3, Alexandre Abizaid4, Ricardo Costa5, J. Ribamar Jr. Costa5, John Yan6, Vinayak Bhat6, Lynn Morrison6, Sara Toyloy6, John Ormiston2
1ZNA Middelheim, Antwerpen, Belgium; 2Auckland City Hospital, Grafton, Auckland, New Zealand; 3Mercy Angiography Unit, Epson, Auckland, New Zealand;4Instituto Dante Pazzanese, Sao Paulo, Brazil, 5Cardiovascular Research Center, Sao Paulo, Brazil,6Elixir Medical Corp, Sunnyvale, California, USA
DESolve™ Investigational use only, 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. DESolve™ Bioresorbable Coronary Scaffold
… and incorporating them into a scaffold that bioresorbs over 1 – 2 years
PLLA-based polymer with excellent durability and flexibility
Proven biocompatibility
Proprietary fabrication and processing technology
Broad range of sizes
3.0, 3.25, and 3.5 mm diameters
2.5, 2.75, and 3.75 available soon
14 and 18 mm lengths
Taking advanced technologies from Elixir’s DES platforms …
Excellent radial strength
Low recoil
Drug release to provide sustained neointimal inhibition
Low drug dose
Myolimus 3µg/mm

4. DESolveTM Differentiating Performance Characteristics
Provides sufficient mechanical support to the vessel wall after implantation and resorbs with in 1-2 years
Self-correcting scaffold properties allow malapposition resolution up to nominal diameter
Substantial safety margin against strut fracture
Wide range of sizes to accommodate a broad range of vessel sizes and lesion lengths
Data on file at Elixir Medical

5. DESolve I FIM Study MULTI-CENTER FEASIBILITY TRIAL
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MULTI-CENTER FEASIBILITY TRIAL
Co-Principal Investigators:
John Ormiston and Stefan Verheye
Angiographic Core Lab: CRC
IVUS/OCT/MSCT Core Labs: CRC
Data Management: Elixir Medical
Single De Novo Native Coronary Artery Lesions (Type A)
Vessel Diameters: – 3.0 mm
Stent Diameters: 3.0 mm
Lesion Length: ≤10 mm
Stent Lengths: 14 mm
Pre-Dilatation required / Post-Dilatation at physician discretion 5
Polylactide-based Bioresorbable scaffold + Bioabsorbable polymer + 3µg per mm Stent Length
Enrollment: 16 patients in Belgium and New Zealand
30d mo mo mo yrs
Clinical Follow-up
Angiographic and /IVUS/OCT/MSCT Follow-up
Principal Angiographic Endpoint: In-Stent Late Lumen Loss at 6 months (QCA)
Device and Procedure (Clinical) Success
Major Adverse Cardiac Events (Death, MI, or TLR)
Key Endpoints: at 1, 6, 12mo and 2-5 yrs
Clinically driven TLR, TVR and TVF at 1, 6, 12mo and 2-5 yrs
Stent thrombosis rates at 1, 6, 12mo and 2-5yrs
ABR, LLL and % volume obstruction, OCT assessment at 6 mo
Anti-Platelet Therapy for 12 months MSCT at 12 and 24 mo

6. Baseline Characteristics
Patient Characteristics, % (n)
(n=15 Patients*)
Age, years (±SD)
70 ± 8.6
Male
66.7 (10/15)
Diabetes mellitus
6.7 (1/15)
Current / former smoker
73.3 (11/15)
Hypercholesterolemia
Hypertension
Previous myocardial infarction
26.7 (4/15)
Previous target vessel CABG or PCI
*one patient did not receive a scaffold and is not included in the modified-intent-to-treat analysis

7. Angiographic Characteristics
Baseline Characteristics, % (n)
(n=14 paired)
RVD (mm)
2.65 ± 0.32
MLD (mm)
0.81 ± 0.29
% DS
70.0 ± 10.5
Lesion Length (mm)
8.95 ± 2.64
Target Vessel, % (n)
LAD
21.4 (3/14)
LCX
35.7 (5/14)
RCA
42.9 (6/14)
Lesion Class (ACC/AHA), % (n) A
B1/B2
64.3 (9/14) C
0.0 (0/14)

8. Angiographic Results In-scaffold Analysis n=14 (paired) RVD (mm)
post-procedure
2.84 ± 0.23
at 6 months
2.78 ± 0.27
MLD (mm)
2.60 ± 0.19
2.41 ± 0.28
% Diameter Stenosis
post procedure
8.05 ± 7.90
12.63 ± 11.37
Acute Recoil (%)
6.4 ± 4.6
Late Lumen Loss (mm) at 6 months
0.19 ± 0.19
Binary Restenosis (%) at 6 months
0.0

9. post-stenting (baseline)
pre-stenting
69-yr old male
hyperlipidemia
hypertension
former smoker
stable angina
post-stenting (baseline)
6M FU
6 month follow-up
6M FU
12M FU

10. IVUS Results MLA = MLA = 5.10 mm2 5.35 mm2 Post-PCI 6 months
In-scaffold Serial Analysis
n=11 (paired)
Post-procedure
6 months
Mean Scaffold Area (mm2)
5.35 ± 0.78
5.61 ± 0.81*
Mean Lumen Area (mm2)
5.10 ± 0.78*
% Volume Obstruction at 6 months --
7.18 ± 3.37
Malapposition (%)
*p=ns between baseline and follow-up

11. OCT Results In-scaffold Cross Section Level Serial Analysis Baseline
6-month
Follow-up
n=10 (paired)
Mean Scaffold area (mm2)
6.57 ± 0.68
6.80 ± 0.85*
Mean NIH Area (obstructive) (mm2) --
0.71 ± 0.36
Mean NIH Obstruction (%)
13.16 ± 5.59
In-scaffold Strut Level Serial Analysis
Total number of Analyzed Struts
2,984
2,575
Frequency of covered Struts/patient (%)
98.68 ± 2.44
Mean NIH Thickness over Covered Struts (mm)
0.12 ± 0.04
*p=ns between baseline and follow-up

12. 12-Month MSCT Results In-scaffold Analysis 12-month Follow-up n=12
Reference Diameter (mm)
 2.9 ± 0.5
Minimal Lumen Diameter (mm)
 2.4 ± 0.4
Mean Diameter Stenosis (%)
 15.9 ± 10.0
Mean Lumen area (mm2)
6.7 ± 3.5
Minimum Lumen area (mm2)
5.1 ± 1.2
Reference area (mm2)
 7.5 ± 2.3
Mean area stenosis (%)
22.4 ± 14.2
MLD and % DS maintained between 6 and 12 months

13. *See event descriptions on following slide
Clinical Outcomes
0 to 360 days
(n=15)
Hierarchical Events, % (n)*
Cardiac Death
1/15
Target Vessel MI
Clinically-Indicated TLR
Other Events
Stent Thrombosis (ARC∫)
0/15
Definite
Probable
*See event descriptions on following slide
∫Cutlip, D, Windecker, S, Mehran,R, et al. Clinical Endpoints in Coronary
Stent Trials: A Case for Standardized Definitions. Circ 2007;115;

14. Clinical Events Cardiac Death Target Vessel MI
Successful scaffold placement in a 81-yr old male with a history of COPD, hypercholestolemia, hypertension, cirrhosis of the liver, cardiomyopathy, chronic renal impairment; pacemaker implantation and moderate aortic valve stenosis.
Admitted on day 295 with unexplained cardiac enzyme elevation; angio showed patent scaffold (RCA) with progression of disease in LAD and ramus.
CABG (non-target vessels) and aortic valve replacement on day 306
Patient hospitalized due to cardiac decompensation, deterioration of renal function, significant uremia, transient metabolic encephalopathy due to underlying liver cirrhosis, and macrocytic anemia. Patient died on day 343
Adjudicated as cardiac death with no evidence of scaffold thrombosis
Target Vessel MI
Successful scaffold placement in a 71-yr old female with a history of smoking, hypercholesterolemia, hypertension and cigarette use
Patient returned to cath lab within 10 min. with chest pain and distal vessel occlusion; sent to emergency CABG; cardiac enzyme elevation post CABG
Adjudicated as MI, abrupt closure distal to scaffold, and TVR with no evidence of scaffold thrombosis
Clinically-Indicated TLR
Successful scaffold placement in a 77-yr old male with a history of hypercholesterolemia and cigarette use
6m angio revealed a 86% prox segment stenosis (in-scaffold 6% DS); treated with DES
Adjudicated at clinically-indicated TLR (in-segment)

15. DESolve ™: International Use Only, Not available for sale in the US
Summary
The DESolve FIM Study demonstrated feasibility of delivery and deployment of the DESolveTM Coronary Scaffold System
The DESolve scaffold provides excellent mechanical support to the vessel wall with low acute recoil
Imaging results demonstrated low neointimal hyperplasia at 6 months with no evidence of late recoil or scaffold shrinkage; MSCT at 12 months confirmed continued neointimal suppression and excellent vessel patency
DESolve ™: International Use Only, Not available for sale in the US

16. DESolve Nx Trial PROSPECTIVE, MULTI-CENTER TRIAL
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PROSPECTIVE, MULTI-CENTER TRIAL
Geographical Principal Investigators:
Alexandre Abizaid; Stefan Verheye;
Joachim Schofer;
Angiographic Core Lab: CRC
IVUS/OCT/MSCT Core Labs: CRC
Data Management: CRC
Single De Novo Native Coronary Artery Lesions (A-B1);
Non-target lesion treatment in a separate epicardial vessel
Vessel Diameters: – 3.5 mm
Stent Diameters: 3.0, 3.25 and 3.5 mm
Lesion Length: ≤14 mm
Stent Lengths: 14 and 18 mm
Pre-Dilatation required / Post-Dilatation at physician discretion 16
Polylactide-based Bioresorbable scaffold + Bioabsorbable Polymer + 5µg per mm Scaffold Length
Enrollment: 120 patients in Europe, Brazil and New Zealand
30d mo mo mo yrs
Clinical Follow-up
Angiographic and /IVUS/OCT/MSCT (subset) Follow-up
Principal Angiographic Endpoint: In-Stent Late Lumen Loss at 6 months (QCA)
Device and Procedure (Clinical) Success
Major Adverse Cardiac Events (Death, MI, or TLR)
Key Endpoints: at 1, 6, 12 mo and 2-5 yrs
Clinically driven TLR, TVR and TVR at 1, 6, 12mo and 2-5 yrs
Stent thrombosis rates at 1, 6, 12mo and 2-5yrs ABR, LLL at 6 mo
Anti-Platelet Therapy for 12 months Subset of 35 pts: Angio, IVUS, OCT assessment at 6 and 24 mo;
MSCT at 12 mo
DESolve™ Investigational use only, not available for sale in the US