The Cardiomind Sparrow DES Program (CARE II) CRT 2010 Washington, DC The Cardiomind Sparrow DES Program (CARE II) Alexandre Abizaid, MD, PhD, FACC Instituto Dante Pazzanese de Cardiologia Sao Paulo - Brazil Columbia University New York - USA

Alexandre Abizaid, MD, PhD Consulting Fees Abbott Vascular, Boston Scientific Corporation, Cordis, a Johnson & Johnson company

Treatment of Small Vessels Requires Specific Design Features Enhanced Flexibility & Deliverability Low profile delivery system Reduced barotrauma (low pressure, minimized extension stent margins) Self-expanding stent Minimal tissue reaction  Biodegradable polymer matrix Specific efficacy in small vessels, diabetics  Sirolimus or Limus type drug

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

CardioMind® Sparrow® Stent Delivery System Detail Wire Tip

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”) 3.0- 3.5mm Stent OD 17-24mm Stent Lengths 3.5μm MicroFusion Coating Drug Coating 4 μm Sirolimus Coating SynBiosys Biodegradable Block Copolymer ~6 μg drug /mm Length Investigational Device, Not for Sale in the US 6

CardioMind Sparrow Delivery System Highlights for CARE II Non-Sterile, reusable, hand-held Power Supply Sterile, Disposable Adapter Delivery System Stent Lead Connection/ Wire Extension

Delivery of the Sparrow® Coronary Stent Investigational Device, For Export Only

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

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

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

CARE II STUDY DESIGN Sparrow DES= 80 Sparrow BM = 80 2 Arm Sub-Set 1:1 randomization Sparrow DES: Sparrow BM 4 Centers CARE II RCT 4:4:3 (80:80:60) Total N=220 + roll in 3 Arm Sub-Set 1:1:1 randomization Sparrow DES: Sparrow BM: Micro-Driver/Driver BM 14 Centers IVUS sub-study (n = 120 @ 7 centers) Sparrow - BM (N=60) Micro-Driver/ Driver Sparrow – DES (~6ug/mm Sirolimus) Sparrow - BM (N=20) Sparrow – DES (~6 ug/mm Sirolimus) Sparrow DES= 80 Sparrow BM = 80 Micro-Driver/Driver = 60 For Superiority Study of Sparrow DES: Sparrow BM Pool common arms together 12 12

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 13

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

CARE II STUDY DESIGN Study Assumptions Adaptive Study Design 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

CARE II PRIMARY ENDPOINT In-stent Late Lumen Loss at 8 months by QCA Primary Analysis Sparrow DES superiority over Sparrow BMS Hierarchal Analyses Sparrow DES superiority over Commercial BMS Sparrow BMS non-inferiority to Commercial BMS Sparrow BMS superiority over Commercial BMS

CARE II Enrollment Status 102 RCT and 138 patients total in CARE II 108 Patients in CardioMind Arm (DES or BMS) Vessels Treated with Sparrow Device LAD - 38.0% LCX – 42.6 % RCA – 19.4% Front Line Use (access/pre and post dil) 72% (78/108) cases w/ Monorail/OTW

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%

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%

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).

CARE II – Device Cross-Overs for CardioMind CARE II Device Success of 92.4% (73/79) Study Definition: Attainment of <30% residual stenosis of the target lesion using the CardioMind device (“in-stent” % diameter stenosis). Reason for Cross-Over Patients Pre- or post- dil dissection (unrelated to stent implantation) 3 Training/Lesion (Ca++) resulting in stent release issues 2 Electrical Fault 1 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).

CARE II 8 –month Follow-up Pre Post 8 month FU Device Success: attainment of <30% residual stenosis of the target lesion using the CardioMind device (“in-stent” % diameter stenosis). (5 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).

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

KEY INCLUSION CRITERIA Single, native de novo target lesion with option to treat one other non-target lesion in a different epicardial vessel Reference vessel diameter 2.0 – 2.75 mm Lesion length < 20 mm Stenosis > 50% and < 100% Lesion is amenable to pre-treatment with balloon angioplasty only Subject agrees to return for 8 month angiographic follow-up

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 8mo 1yr 2yr 3yr 4yr 5yr Clinical / Telephone Follow-Up Angiographic / IVUS Follow-Up @ 8 mo Primary Endpoint: In Stent Late lumen loss @ 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 26 26