1. Harvard Medical School Brigham and Women’s Hospital
CARDIOMIND® stent-on-a-wire self-expanding microstent: Results from CARE I (2-yr follow-up) and CARE II Update (Sirolimus-eluting Microstent)
Laura Mauri MD, MSc.
Harvard Medical School
Brigham and Women’s Hospital

2. Laura Mauri, MD DISCLOSURES
Laura Mauri has consulted for Cordis Corporation and Medtronic Vascular
Research support to Harvard Clinical Research Institute from:
Abbott, Boston Scientific Corporation, Cordis Corporation, Medtronic, Inc., Bristol-Myers Squibb/Sanofi-Aventis Pharmaceuticals Partnership, Eli Lilly and Company and Daiichi Sankyo Company Limited

3. CardioMind® Sparrow® Stent Delivery System: “Stent-in-a-Wire”
CardioMind® Sparrow® Stent Delivery System: “Stent-in-a-Wire” .014” Guidewire Design
2 mm
Sparrow
Balloon
Exp Stent
Investigational Device, Not for Sale in the US

4. CardioMind® Sparrow® Stent Delivery System

5. The CardioMind® Sparrow® Stent Delivery System
.014” Guide Wire Platform
2 cm Pt Coil Tip
Battery Powered Electrical Release
9 VDC & 15 VPP (100kHz AC)
0.2 milliAmp
Stent
Nitinol
Closed Cell
Ultra Thin Strut (.0024”)
mm Stent OD
17-24mm Stent Lengths
3.5μm Platinum Blend
Coating
Drug Coating
4 μm Sirolimus Coating
SynBiosys Biodegradable
Block Copolymer
~6 μg drug /mm Length
Investigational Device, Export Only 5

6. The CardioMind® DES Sparrow® Stent:
Sirolimus in the Biodegradable SynBiosys Matrix

7. Sparrow® Sirolimus-eluting Stent Characteristics (SynBiosys PLA biodegradable copolymer matrix)7

8. Pathology Results in Porcine Model: Sparrow DES stented vessels recovers to bare metal type of tissue response at 180 days
28 Day
90 Day
180 Day
Bare Metal
Sparrow
DES Sparrow
Sirolimus
in SynBiosys
PLA/PLGA
copolymers

9. CARE I
CARE I - Bare Metal Sparrow Stent (n=22, St Vincent’s Melbourne and Dante Pazzanese)
Single De Novo Native Coronary Artery Lesions
Vessel Diameters: 2.0 – 2.6 mm
Stent Diameters: 2.5 – 3.0 mm
Lesion Length: ≤14 mm
Primary Stent Length: 18 mm
12 mm Length for Bailout Only
Pre-Dilatation and Post-Dilatation Required
Clinical Follow-Up
30d 6mo 9mo 12 mo 2yr 3yr
Angiographic / IVUS ( 22 pts) Follow-Up
Primary Endpoint: MACE at 30 days (death, MI and TVR)
Key Secondary Endpoints: Sub acute thrombosis (SAT)
Device, Lesion and Procedure Success
MACE at hospital discharge, 6, 9 & 12 mos
Clinically driven TLR and TVF at 6, 9 & 12 mos
ABR, LL and % volume obstruction at 6 & 12 mos
Anti-Platelet Therapy for 3 months 9

10. CARE I – Baseline Demographics (n=22 enrolled)
Characteristic
Aggregate
Age, Years
61.94±10.90
( )
Male
63.6% (14/22)
Prior MI
45.5% (10/22)
Prior PCI
27.3% (6/22)
History of Diabetes
50.0% (11/22)
History of Hypertension
72.7% (16/22)
Hyperlipidemia
86.4% (19/22)
Current Smoker
36.4% (8/22)
Family history of CAD
54.5% (12/22)
History of Angina-Stable
68.2% (15/22)
History of Angina-Unstable
9.1% (2/22)
LVF (Normal)

11. CARE I Results – Lesion Characteristics (n= 22 target lesions)
Aggregate (n=22)
Target Vessel
RCA
36.4% (8/22)
LAD
13.6% (3/22)
LCX
50.0% (11/22)
Mean RVD (mm)
2.20±0.20
( )
Mean Lesion Length (mm)
10.86±3.19
( )

12. CARE I – Baseline QCA (22 enrolled, 21 treated, 20 w/6 Mo. F/U)
Characteristic
Aggregate
Patients with 1 Vessel Disease
81.8% (18/22)
Patients with 2 Vessel Disease
18.2% (4/22)
Device Success
96% (24/25)
Procedural Success
95% (21/22)
Pre-Procedure % Diameter Stenosis (n=20 lesions)
71.31±13.17
( )
Post-Procedure % Diameter Stenosis (n=20 lesions)
15.78±7.07
( )
MLD Pre-Procedure (mm)
0.62±0.27
( )
MLD Post-Procedure (mm)
1.91±0.27
( )

13. Serial Volume Index Changes at 6 Mo
CARE I
Serial Volume Index Changes at 6 Mo
(in-stent segment)
Stent Volume Index
Vessel Volume Index
Plaque Volume Index*
(mm3/mm)
(mm3/mm)
(mm3/mm)
8.41.7
8.41.7
+13%
4.50.9
4.41.0
4.00.9
3.90.9
p=NS
P=0.0010
p=0.026
Baseline
Follow-up
Baseline
Follow-up
Baseline
Follow-up
Serial 3D IVUS analysis: n=13
Stanford
* Peri-stent PVI

14. IVUS Serial Volume Index
CARE I
IVUS Serial Volume Index
No Changes 6M v 12M (Reference segment)
Proximal reference
Distal reference
(mm3/mm)
(mm3/mm)
8.90.9
8.81.6
Vessel Volume Index
6.01.0
5.70.7
4.70.8
5.01.8
Plaque Volume Index
2.31.3
2.00.8
4.20.8
3.81.0
Lumen Volume Index
3.71.0
3.71.1
6 Mo
12 Mo
6 Mo
12 Mo
Serial 3D IVUS analysis: n=6
Stanford

15. CARE I - 6 & 12 Month QCA Results
Characteristic
6 Months
Aggregate (n=19)
12 Months
Aggregate (n=10)
RVD (mm)
(19)
In-stent % DS
( )
( )
In-segment % DS
( )
( )
In-stent MLD (mm)
( )
( )
In-segment MLD (mm)
( )
( )
In-stent LLL (mm)
( )
( )
In-segment LLL (mm)
( )
( )
Binary Restenosis
21.1% (4/19)
20% (2/10)

16. CARE I ( Bare Metal Stent) Clinical Follow-up Results to 12 months
30 Days
6 Months
12 Months
MACE
2/21 (9.5%)
Death
1/21 (4.7%) MI
0/21
TLR
Stent Thrombosis
Possible
Probable
Definite

17. CARE I Final Results - 24 Months
CEC-Adjudicated Safety Endpoints
Results (n = 21 pts)
In-hospital MACE
0/21 (0%)
30 Days
6 Months
1/21 (4.8%)
8 Months
2/21 (9.5%)
12 Months
24 Months
Major Vascular Events
Stent 30 Days 17

18. CARE I
CARE I – Conclusions
CARE I Bare Metal Nitinol stent evaluated in a complex patient set
50% Diabetic
Average RVD 2.20 mm
Safety Demonstrated in Feasibility Study
Low MACE rates through 24 months
Angiographic binary restenosis at 12 months = 20%
13% Stent expansion seen in IVUS at 6 months
May offset any increases in NIV
Serial IVUS shows stent expansion unchanged from 6 to 12 mo
Sparrow Nitinol stent successfully delivered on a guidewire platform
DES platform in evaluation in CARE II

19. CARE II Randomized Clinical Study- 220 RCT Patient Planned Enrollment
Single De Novo Native Coronary Artery Lesions
2 Vessel (Target and Non-Target Vessel) Treatment allowed
Vessel Diameters: 2.0 – 2.75 mm
Lesion Length: ≤20 mm
Primary Stent Lengths: 17 & 23/24 mm
Pre-Dilatation and Post-Dilatation Required
30d 6mo mo 1yr 2yr 3yr 4yr 5yr
Clinical / Telephone Follow-Up
Angiographic / IVUS 8 mo
Primary Endpoint: In Stent Late lumen 8 mo
Key Secondary Endpoints: MACE at hospital discharge, 30 D, 8, 12 & 24 mo
Sub acute thrombosis (SAT)
Device, Lesion and Procedure Success
Clinically driven TLR, TVR, TVF at 8, 12 & 24 mo
QCA & IVUS (subset) endpoints at 8 mo
Anti-Platelet Therapy for 8 months 19 19

20. CARE II Investigational Sites
Region * = enrolling
Principal Investigator
Institution
Brazil
Sao Paulo*
Uberlandia*
Alexandre Abizaid, MD, PhD, CARE II PI
Roberto Botelho, MD, PhD
Instituto Dante Pazzanese
Instituto Do Coracao Do Triangulo Mineiro
Australia / New Zealand
Melbourne*
Adelaide*
Brisbane*
Sydney
Auckland, NZ
Christchurch, NZ
Robert Whitbourn, MD, CARE II Regional PI
Ian Meredith, MD
Stephen Worthley, MD
Darren Walters, MD
Craig Juergens, MD
John Ormiston, MD
Dougal McClean, MD
St. Vincent's Hospital
Monash Medical Center
Royal Adelaide Hospital
Prince Charles Hospital
Liverpool Hospital, NSW
Auckland City Hospital
Christchurch School of Med.
Southeast Asia
Singapore*
Singapore
Malaysia*
Koh Tian Hai, MD
Huay Cheem Tan, MD
Robaayah Zambahari, MD
National Heart Centre
National University Hospital
Institut Jantung Negara
Europe
Belgium*
Belgium
Germany*
Switzerland*
Spain*
The Netherlands
Stefan Verheye, MD, PhD
William Wijns, MD
Bernhard Witzenbichler, MD
Stephan Windecker, MD
Carlos Macaya, MD
Pieter Stella MD, Pierfrancesco Agostoni MD
AZ Middelheim, Antwerpen
OLV Hospital, Aalst
Charite-Benjamin Franklin, Berlin
Swiss Cardiovasc. Ctr., Bern
Hospital Clinico San Carlos Servicio de Hemodinamica
University Hospital Centre, Utrecht 20

21. CARE II Participating Institutions
Study Management
Institution
Data Management
Clinical Events Committee
Data Safety Monitoring Board
CRF
Core Labs
Angiography
IVUS
EKG
Stanford
CRO Monitoring
Australia/Asia Pacific
Brazil
Europe
PCRG
CRC
MedPass 21

22. CARE II Study Design Study Assumptions 4:4:3 Randomization
80 Sparrow DES: 80 Sparrow BMS: 60 MicroDriver/Driver BMS
LLL Standard Deviations (SD) expected to differ between DES and BMS
Adaptive Study Design
First 100 randomized patients to be analyzed after 8 month
follow-up
able to increase sample size up to 25% if actual SD exceeds planned SD

23. CARE II Enrollment Status
138 patients total in CARE II
108 Patients in CardioMind Arm (DES or BMS)
Front Line Use (access/pre and post dil)
72% (78/108) cases w/ Monorail/OTW

24. CARE II – Baseline Demographics (n=100 patients)
Characteristics
CARE II (n=100)
Mean Age
63 yr
Male
66%
History of Hypertension
83%
History of Hyperlipidemia
88%
History of Smoking
67%
History of Diabetes
33%
History of MI
37%

25. CARE II – Pre- and Post- Procedure QCA
Characteristics
CARE II (n=100)
Target Vessel
LAD 42
Left Circumflex 35
RCA 23
Pre-Procedural QCA
Average Lesion Length (mm)
14.47
Reference Vessel Diameter (RVD, mm)
2.32
Percent Diameter Stenosis (% DS)
71%
Post- Procedural QCA
% Diameter Stenosis, In-lesion (Stent + 5mm Edge)
18.27%
% Diameter Stenosis, In-stent
10.34%
Acute Gain (mm)
1.45
Final TIMI Flow 3
100%

26. CARE II – Acute Performance Results for CARE II CardioMind Patients
Characteristics
CardioMind Implantations (n=79)
Device Success
92.4% (73/79)
Lesion Success
100% (79/79)
Procedural Success
94.9% (75/79)
Device Success: attainment of <30% residual stenosis of the target lesion using the CardioMind device (“in-stent” % diameter stenosis). (6 cross-overs)
Lesion Success: attainment of < 30% residual stenosis using any percutaneous method.
Procedure Success: Lesion Success without the occurrence of in-hospital MACE (total of 4 in-hospital NQMIs). 26

27. CARE II DES Implantation
60 yr Female with diffuse disease in LAD (2.4mm RVD)
2.75mm X 24mm DES Stent
Pre Post month FU
Courtesy of Roberto Botelho M.D. PhD Instituto do Coração do Triângulo; Uberlândia-MG / Brazil

28. CONCLUSIONS
CardioMind Sparrow Stent System successfully used > 70% as front line wire
Used with RX/monorail and over-the-wire catheters
Femoral and Radial access
CARE II randomized clinical trial with Sirolimus-eluting and Bare Metal Sparrow Stent in progress
138 patients enrolled at 13 centers
Planned interim analysis at 8 Mo Follow-up of 102 RCT patients - April 2010
Intracranial clinicals to be initiated in 2010
Atherosclerotic disease, aneurysm, acute stroke indications