Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst The AMEthyst Trial A prospective randomized controlled study of the Medtronic Interceptor® PLUS Coronary Filter System for PCI of Degenerative SVG Dean Kereiakes M. Turco, B, McLaurin, R. Feldman, N. Farhat, J. Breall and M.Foster on behalf of the study investigators Late Breaking Clinical Trial Presentation TCT 2007

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst Dean J. Kereiakes, M.D., FACC Disclosure: SCIENTIFIC ADVISORY BOARD: Cordis/Johnson & Johnson Boston Scientific Corporation, Inc. Abbott Vascular Core Valve RESEARCH GRANT SUPPORT: Boston Scientific Corporation Inc. Abbott Vascular Medtronic Daiichi Sankyo CONSULTING: Eli Lilly Co. Daiichi Sankyo Medtronic

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst AMEthyst Medtronic Interceptor PLUS Filter Catheter Study Device Nitinol Filter Basket 71% Open pore area Low profile 2.7 Fr ” wire Actuator handle 100 µ distal pores µ proximal openings

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst AMEthyst InvestigatorHospital # Patients B. McLaurin Anderson Area Med. Ctr. 65 R. Feldman Munroe Regional Med. Ctr. 63 N.Farhat EMH Regional Hospital 62 D. Kereiakes* Christ Hospital 44 J. Breall Indiana University Med. Ctr. 44 M. Foster Providence Hospital 32 A. Rabinowitz Texsan/SW Texas 25 J. Patterson Forsyth Med. Ctr. 24 A. Szyniszewski St. Joseph Mercy 23 K. Smith University of Florida 20 * Principal Investigator Enrollment : 73 U.S. Centers - “Top 10”

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst Randomized, Open Label, Multicenter Trial AMEthyst: Study Design Primary Endpoint: MACE (death, MI, repeat revascularization) at 30 days MACE (death, MI, repeat revascularization) at 30 days Secondary Endpoints: Elevated CK, CK-MB during index hospitalization, in hospital MACE, device and clinical success Elevated CK, CK-MB during index hospitalization, in hospital MACE, device and clinical success Primary Endpoint: MACE (death, MI, repeat revascularization) at 30 days MACE (death, MI, repeat revascularization) at 30 days Secondary Endpoints: Elevated CK, CK-MB during index hospitalization, in hospital MACE, device and clinical success Elevated CK, CK-MB during index hospitalization, in hospital MACE, device and clinical success 30 days De Novo or restenotic lesions of Saphenous Vein Grafts Vessel Diameter: mm De Novo or restenotic lesions of Saphenous Vein Grafts Vessel Diameter: mm Control DEP* n = 200 Control DEP* n = 200 Interceptor® PLUS n= 600 Interceptor® PLUS n= 600 2:1 randomization Clinical Procedure *GuardWire® or FilterWire TM EZ at physician’s discretion

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst AMEthyst Includes multivessel PCI with following restrictions: Total of 2 lesions in up to 2 native vessels (non-target lesions [NTL]) NTLs successfully treated before enrollment to study Unlimited target lesions (TL) in up to 2 SVG’s Key Inclusion Criteria: Subjective or Objective evidence of ischemia TL in a SVG >50 and 50 and <100% stenosed Target Vessel has TIMI 1 flow or greater Key Exclusion Criteria: Recent Myocardial Infarction (MI) >24 hrs, with + CK-MB, or Acute MI Surgery within 30 days LVEF <25% TL has been previously stented TL within 5mm of graft ostium or <35mm from graft-native anastomosis Subject Selection Criteria

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst AMEthyst Core Labs QCA Core Lab –Brigham and Women’s Hospital, Boston, MA, USA –Jeffrey J. Popma, MD Data Coordinating Center –Harvard Clinical Research Institute, Boston, MA, USA –Laura Mauri, MD ECG Core Lab –Harvard Clinical Research Institute, Boston, MA, USA –Peter Zimetbaum, MD Clinical Events Committee/DSMB –Harvard Clinical Research Institute, Boston, MA, USA –Donald Cutlip, MD

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst 2:1 Randomization Ratio AMEthyst Sample Size Calculation INITIAL ASSUMPTIONS: D30 MACE rate for Interceptor and Control group <10% Power 80% 1-sided alpha error 5% Delta for equivalence 5.5% Interceptor PLUS 400 patients Control Device 200 Patients 600 Patients SAFER Trial Borrow additional patients using Bayesian methods

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst Revised Sample Size Calculations DSMB Safety Review 04/18/05 (first 300 patients) No Safety Issues However: Observed control 30D MACE <<10% ? Pooling with SAFER patients ? Study Adequately Powered Continue Study Add 200 patients AMEthyst Revised Assumptions 30D MACE rate for control and Interceptor assumed < 6% Power 80% 1-sided alpha error 5% Delta for equivalence 4.5%

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst AMEthyst Final Patient Distribution and Follow-up Patients Enrolled n=800 Randomized 2:1 Interceptor n = 533 Control DEP n = 267 Clinical F/U 30 days 258/ % Clinical F/U 30 days 522/ % GuardWire n= 194 FilterWire* n=73 *Additional optional control device added per Amendment Feb 2006

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst AMEthyst Patient Demographics Interceptor PLUS n=533ControlDEP n=267 n=267 p value Male (%) Age (yrs+SD) Diabetes (%) Hypertension (%) Dyslipidemia (%) Unstable Angina (%) Left Ventricular Ejection Fraction (%+SD) Prior PCI to target lesion (%)

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst AMEthyst Interceptor n = 533 Control n = 267 p value Age of SVG (yrs) B2/C lesions (%) RVD (mm) Lesion Length (mm) Pre-procedure MLD (mm) Post- procedure In-Stent MLD (mm) In-Stent MLD (mm) In-stent % stenosis In-stent % stenosis Procedural and Lesion Characteristics

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst SVG Degenerative Score (% lumen irregularities ) Am J Cardiol 2005; 95(2) (0-25%) 1 (26-50%) 2 (51-75%) 3 (76-100%)

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst Interceptor n = 533 Control n = 267 p value % % % % AMEthyst Extent of SVG Degeneration

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst Interceptor n = 533 Control n = 267 p value Number of Stents/Pt 1.28± ± Total Stent Length (mm) 25.8 ± ± Stent:Lesion Length 1.58 ± ± Stent diameter 3.0 mm (%) 3.0 mm (%) mm (%) 3.5 mm (%) 4.0 mm (%) 4.0 mm (%) Max Deployment (ATM) 16.1 ± ± Max Inflation (ATM) 16.4 ± ± GP IIb/IIIa Inhibitor (%) AMEthyst Procedural Characteristics

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst Interceptorn=533Controln=267 p Value Death % (#) (2) 0.11 MI % (#) 7.3 (39) 5.2 (14) 0.30 Q Wave Q Wave Non-Q wave Non-Q wave 6.9 (37) 4.5 (12) 0.21 Stent Thrombosis % (#) 00 MACE % (#) 7.3 (39) 5.6 (15) 0.46 AMEthyst Outcomes – in hospital

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst Device success defined as delivery, deployment and retrieval of the assigned device Clinical success defined as delivery, deployment and retrieval of the assigned device with no in hospital MACE Interceptorn=533Controln=267 p value Device Success (%) Clinical Success (%) Final TIMI Flow (%) AMEthyst Device Effectiveness (ITT population)

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst Interceptorn=501Controln=250 p Value p Value Death % (#) (2) 0.11 MI % (#) 8.0 (40) 6.0 (15) 0.37 Q Wave Q Wave 0.4 (2) 0.8 (2) 0.60 Non Q wave Non Q wave 7.6 (38) 5.2 (13) 0.28 Stent Thrombosis % (#) 0.4 (2) 0.8 (2) 0.60 TLR % (#) 0.2 (1) 0.4 (1) 1.00 TVR (non-TL) % (#) (3) 0.04 MACE % (#) 8.0 (40) 7.2 (18) 0.77 AMEthyst Outcomes to 30 days

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst Control (n=18/250) Interceptor (n=40/501) 7.2% 8.0% 30 day MACE P for Non-Inferiority (for delta=4.5%) P for difference 0.77 AMEthyst Primary Endpoint

Caution: Investigational Device. Limited by Federal (USA) Law to investigational use. AMEthyst Conclusions The Interceptor® PLUS filter is not inferior in safety and efficacy to 30 days when compared with currently approved DEP device standards (GuardWire, FilterWire EZ). A trend toward less frequent TVR (non-TL) to 30 days observed following Interceptor (vs. Control DEP) Overall MACE to 30 days in DEP device-treated patients appears to be less frequent in contemporary PCI practice and deserves further study. AMEthyst