1. DESSOLVE I Trial Results
The Micell Technology and
Program Update
DESSOLVE I Trial Results
Mathias C. Vrolix, MD
ZOL, Genk, Belgium

2. Disclosure Statement Nothing to Disclose CAUTION:
The MiStent® Sirolimus DES is an investigational device that is not approved by the FDA for sale or use in the United States.

3. DES - Moving Away from Durable Polymers
Durable polymers have been linked with very late (>1 yr) stent thrombosis events due to:
Stimulus for chronic inflammation
Local allergic reactions
Incomplete re-endothelialization
Positive remodeling
Acquired incomplete stent apposition
References:
Cook S, et al. Correlation of Intravascular Ultrasound Findings With Histopathological Analysis of Thrombus Aspirates in Patients With Very Late Drug-Eluting Stent Thrombosis. Circulation. 2009;120:
Joner M, et al. Pathology of Drug-Eluting Stents in Man: Delayed Healing and Late Thrombotic Risk. J Am Coll Cardiol. 2006;48:193–202
Cook S, et al. Incomplete Stent Apposition and Very Late Stent Thrombosis After Drug-Eluting Stent Implantation. Circulation. 2007;115:

4. MiStent Bioabsorbable Coating
Rapid elimination of polymer
with controlled release of drug
POLYMER – Absorbable Coating
Known Polymer – PLGA
Coating is cleared from stent in days leaving a BMS
Eliminated from tissue in 90 days
DRUG
Known Drug – SIROLIMUS
Crystalline form (for modified release) contained within the polymer
Formulation provides drug stability for sustained release with no burst
Extensively tested proven drug, highly effective for suppression of neointimal hyperplasia
STENT and DELIVERY SYSTEM
Known Stent – GENIUS® Magic Stent and Rx Catheter
CE Mark thin strut (64µm) cobalt chromium coronary stent
Flexible and trackable with visibility and accuracy
Illustrative SEM of
MiStent DES Stent Platform

5. Safety & Efficacy in Porcine Model
Significantly lower inflammation than BMS through 90 days in challenging overlap configuration. Significantly less NIH through 30 days.
Lumen
VER, 2x
30 day OLP
MiStent DES
*P < 0.05
Lumen
VER, 2x
30 day OLP
Vision BMS
*P < 0.05

6. DESSOLVE I Clinical Study
First-In-Human Trial
Enrollment: 30 patients at 5 sites with de novo, type A/B1/B2 lesions
MiStent DES: mm diameter x 19 or 23 mm length
Evaluations:
Primary: In-stent LLL in groups of 10 patients at 4, 6 and 8 months follow-up
Safety: MACE - all death, MI (QW and NQW), and TVR
Imaging: Angiography, IVUS and OCT evaluations at each time point
Follow-up: Patients will be followed for 5 years
30 Pts Enrolled
10 Pts
4-Months
Angio, IVUS, OCT
10 Pts
8-Months
Angio, IVUS, OCT
All patients evaluated for clinical events at 8 months
10 Pts
6-Months
Angio, IVUS, OCT

7. Investigators and Sites
Co-PRINCIPAL INVESTIGATORS William Wijns, MD Belgium John Ormiston, MD New Zealand
Belgium
William Wijns, MD, Cardiovascular Center, Aalst
Mathias Vrolix, MD, ZOL, Genk
New Zealand
Jim Stewart, MD, Mercy Angiography Unit, Auckland
Mark Webster, MD, Auckland City Hospital, Auckland
Australia
Robert Whitbourn, MD,
St. Vincent’s Hospital, Melbourne

8. CROs and Core Labs DATA MANAGEMENT and SAFETY, CEC, DSMB
Harvard Clinical Research Institute, Boston, MA
CORE LABORATORIES
Angiographic Core Yale, New Haven, CT
Alexandra Lansky, MD
IVUS Core Stanford, Stanford, CA
Peter Fitzgerald, MD, PhD
OCT Core HVI, Cleveland, OH
Hiram Bezzera, MD, PhD and Marco Costa, MD, PhD
MONITORING GROUPS
genae Associates, Inc.
Pacific Clinical Research Group

9. Inclusion/Exclusion Criteria
Key Criteria
Patient:
Stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia;
No recent Q wave MI (<72 hrs) or no elevated cardiac biomarkers
Target Lesion:
Planned single, de novo, types A, B1 or B2 coronary lesions (according to the ACC/AHA classification) in the native coronary artery with >50% diameter stenosis;
Vessel diameter 2.5 to 3.5 mm - maximum 23 mm long stent;
Exclude if highly calcified, tortuous, thrombus present, proximal angulation;
Exclude if located at side branch >2.5mm, ostial location, previously treated vessel
Non-Target Lesion:
May treat one critical non-target lesion in another vessel prior to target lesion

10. DAPT Pre-Procedure: Patient DAPT Compliance at 8-months:
Recommendations:
DAPT recommendations in accordance with ACC/AHA/SCAI PCI Practice Guidelines
Aspirin indefinitely
Plavix® (clopidogrel) for 12 months
minimum of 6 months taking local country recommendations into consideration
Pre-Procedure:
87% of patients were already on DAPT
Patient DAPT Compliance at 8-months:
Aspirin: 100% patients are continuing to take daily aspirin
Plavix : 80% (24/30) remain on daily Plavix of 75 mg at 8 months
20% (6/30) discontinued at 6 months

11. Baseline Patient Characteristics
Demographics
(N=30 patients)
Age
Mean ± SD (N)
62.57 ±9.95 (30)
Range (Min, Max)
(44.00,86.00)
Gender
Male
73.3% (22/30)
Female
26.6% (8/30)
Risk Factors
(N=30 patients) MI
16.7% (5/30)
PCI of Non-TV
30.0% (9/30)
Previous PCI of TV
10.0% (3/30)
Diabetes Mellitus
23.3% (7/30)
Hypertension
76.7% (23/30)
Hypercholesterolemia
86.7% (26/30)

12. Baseline Lesion Characteristics
(N=30 patients)
Vessel Location
LAD
36.7% (11/30)
LCX
23.3% (7/30)
RCA
40.0% (12/30)
Length, mm
1<=Length<10 mm
26.7% (8/30)
10<=Length<20 mm
70.0% (21/30)
Length>=20 mm
3.3% (1/30)
Calcification, (Moderate/Severe)
Moderate
Severe
Lesion Classification A
20.0% (6/30) B1
43.3% (13/30) B2 C
13.3% (4/30)

13. Procedural Characteristics
Measure
(N=30 patients)
RVD (mean ±SD)
2.9 ±0.3
Lesion Length (mean ±SD)
13.2 ±3.8
Mean %DS Pre Procedure (±SD)
69.3 ±7.7
Max Stent Deployment Pressure (atm)
13.9 ±2.7
Number of non-TV lesion treated
26.7 (8/30)

14. Procedural Outcomes Measure Device Success 96.6% (29/30)*
(N=30 patients)
Device Success
96.6% (29/30)*
Lesion Success
100%
Procedural Success
*MiStent DES was unable to cross the lesion due to calcification in the artery.
A subsequent MiStent was implanted.

15. Angiographic Parameter
Procedural Outcomes
Angiographic Parameter
Mean (±SD)
(n=30 pts)
Range
(min-max)
In-Stent %DS
2.26% (±7.44)
-12.43% %
In-Lesion %DS
13.37% (± 7.39)
-2.53% %
In-Stent MLD (mm)
2.83 (±0.30)
In-Lesion MLD (mm)
2.51 (±0.28)

16. Safety Events MiStent Total MACE 3.33% (1)** TLF 0% TVF
as adjudicated by CEC
MiStent
(N=30 pts)
Total MACE
3.33% (1)**
TLF 0%
TVF
Peri-procedural MI
6.7% (2)***
Stent Thrombosis
* MACE defined as death, MI (QWMI and NQWMI) and TVR
** non TV, NQWMI: increased troponin following diagnostic angiogram at 44 days post-index procedure
*** ppmi: CK-MB elevation only post-procedure

17. Primary Endpoint – In-Stent Late Lumen Loss
Angiographic Results
Primary Endpoint – In-Stent Late Lumen Loss
In- Stent LLL (mm)
4-Month Group
(n=10)
6-Month Group
8-Month Group
Mean
(± SD)
0.01
(± 0.12)
0.21*
(± 0.36)
0.09
(± 0.10)
Median
Range
0.03
-0.22 to 0.21
0.10
-0.03 to 1.20
0.08
-0.01 to 0.28
Includes outlier with lesion outside proximal end to stent that grew into the stent.
Excluding outlier the mean 6-mo LLL was 0.1mm

18. Angiographic Results
Patient Level In-stent LLL (QCA) by Follow-Up Group
No Binary Restenosis
Linear Regression indicates minimal change in Late Lumen Loss between 4 and 8 Months
In-stent LLL (mm)

19. IVUS Results Demonstrate Low Neointimal Hyperplasia
consistent with the low in-stent late loss seen angiographically
Parameter*
4-Month Group
Mean (SD)
(n=9)
6-Month Group
(n=7)
8-Month Group
(n=8)
Neointimal Obstruction (%)
5.2 (±3.2)
8.0 (±3.1)
10.9 (±4.6)
Neointimal Volume Index (mm3/mm)
0.3 (±0.2)
0.7 (±0.4)
0.8 (±0.5)
*1 case (4 month), 3 cases (6 months) and 2 cases (8 month) were not interpretable

20. IVUS at 8M Follow-up Proximal Distal Proximal Distal
%NIH: 4.3%, maxCSN 16.6%
002_001: 3.0x23mm for LCX

21. Thin homogeneous tissue coverage
OCT Results
High rate of stent strut coverage at all time points
Stent Strut Coverage
Mean
4-Month 84.7%
6-Month 93.4%
8-Month 96.5%
Thin homogeneous tissue coverage

22. Conclusions
MiStent DES: Designed for the coating to be cleared off the stent in days leaving a BMS with sustained drug release
Efficacy
Angiography & IVUS evaluations indicate good inhibition of neointimal hyperplasia
In-stent LLL at 8 months was 0.09 mm
Percent neointimal obstruction at 8 months was 10.9%
No binary restenosis or revascularizations
Essentially no change in extent of NIH from 6 to 8 months follow up
Safety
OCT demonstrates good strut coverage 96.5% at 8 months
MACE events: 1 non-TV, NQWMI at 44 days post-procedure
No stent thrombosis

23. DESSOLVE II Design Primary Endpoints Sub-Study Evaluations
Prospective, unbalanced (2:1) randomized, superiority trial
183 patients enrolled at 26 sites
Primary Endpoints
Efficacy: In-stent LLL at 9 months
Safety: MACE at 9 months
Sub-Study Evaluations
OCT in 30 patients
Endothelial Function Testing in 42 patients
Ability of target vessel to heal with return of endothelial function after stent deployment
Status Enrollment Complete – Results Q3-2012
183 Enrolled
2:1 Randomization
MiStent DES
122 pts
Endeavor® Sprint
61 pts

24. The Micell Technology and Program Update DESSOLVE I Trial Results
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