CRT 2010 Washington USA Feb 21 23 2010

CRT 2010 Washington, USA, Feb 21 -23, 2010 LV Reduction: Update on the PARACHUTE Trials Horst Sievert, Nina Wunderlich Cardio. Vascular Center Frankfurt, Germany

DISCLOSURES Horst Sievert, MD Consulting Fees – Access. Closure, Inc. , AGA Medical Corporation, Angiomed, Ardian, Inc. , Arstasis, Inc. , Avinger, Bridge. Point Medical, Cardio. Kinetix, Inc. , Cardio. MEMS Inc. , Coherex Medical, Inc. , CSI Medical, Endo. Cross, Boston Scientific Corporation, ev 3, Inc. , Flow. Cardia, Inc. , W. L. Gore & Associates, Inc. , Abbott Vascular, Lumen Biomedical, Kensey Nash Corporation, Kyoto Medical, NDC, NMT Medical, Inc. , OAS, Occlutech, Osprey Medical, Inc. , Ovalis, Inc. , Pathway Medical Technologies, Inc. , Pfm Medical, Inc. , Pendra. Care, Percardia Inc. , Remon Medical Technologies, ROX Medical, Sadra Medical, Sorin Group, Spectranetics, Square One Medical, Viacor, Inc. , St. Jude Medical, Medinol Ltd. , Lutonix, Inc. Grants/Contracted Research – Abbott Vascular, Access. Closure, Inc. , AGA Medical Corporation, Angiomed, Boston Scientific Corporation, Cardio. Kinetix, Inc. , Co. Aptus Medical Corporation, Cordis, a Johnson & Johnson company, CSI Medical, Edwards Lifesciences LLC, ev 3, Inc. , W. L. Gore & Associates, Inc. , Kensey Nash Corporation , Mind Guard, NDC, Neovasc, NMT Medical, Inc. , Percardia Inc. , Sorin Group, St. Jude Medical, Terumo Medical Corporation, Top. Spin Medical Ltd. , St. Jude Medical, Lumen Biomedical Ownership Interest (Stocks, Stock Options or Other Ownership Interest) – Cardio-Kinetics Inc. , Access. Closure, Inc. , Co. Aptus Medical Corporation, Lumen Biomedical, Cierra I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation. I intend to reference PFO, ASD devices, carotid stents, and EPD.

Dor Procedure Aneurysm Resection • Reduces the LV size and LV wall stress • Improves contractility of remote myocardium • The Parachute (or VPD implant) mimics the Dor procedure Athanasuleas CL et al, JACC 2004

Parachute Effects On scarred LV wall • Excludes scarred apex • Prevents further dilatation • Restores conical apex On remote myocardium • • Reduces LV wall stress Increases contractility Prevents further remodeling Promotes reverse remodeling Overall • • • Reduces diastolic & systolic volume Increases ejection fraction Reduces LVED pressure

VPD Implant Procedure

Cardiokinetix System Components Ventricular Implant: • 75 mm & 85 mm diameter • Nitinol struts • e. PTFE membrane • Radiopaque Pebax polymer foot Investigational Device. Limited by Federal (US) law to Investigational Use Only.

Vascular Access and Delivery System 14 & 16 French Guide Catheters Delivery System Investigational Device. Limited by Federal (US) law to Investigational Use Only.

Delivery Catheter • • • Balloon inflation port • Distal balloon Proximal injection port Implant detachment knob

VPD Implant: GLP Animal Study Tissue In-Growth 3 Weeks Post Implant

Ejection Fraction Animal Study % n. s. P<0. 001

PARACHUTE Clinical Studies ● EU-PARACHUTE trial ● ● initiated in October, 2005 - completed in June, 2007 US-PARACHUTE trial ● initiated in March, 2008 - completed in June, 2009 ● Current status: 39 patients enrolled world-wide ● 6 -month data are available from all EU- and from 7 US patients

EU and US PARACHUTE Clinical Studies • Safety and feasibility trials • prospective, single-arm, multicenter • patients with heart failure due to ischemic heart disease • clinical and echo follow-up at 1, 3, 6, 9, 12 months and then yearly to 5 yrs • LV gram after 6 months (optional, EU only) • CT/MR imaging (brain, kidney and heart) follow-up at 6 months

Key Inclusion Criteria • Heart Failure • Apical akinesia/hypokinesia due to prior MI • NYHA Class II-IV • Optimal medical therapy • Ejection fraction < 40% • Appropriate LV anatomy to accommodate PARACHUTE

Key Exclusion Criteria • PCI, CABG, ICD, CRT > 60 days prior to enrollment • Acute MI < 60 days prior to enrollment • Thrombus in LV or LA • History of bleeding or blood disorder • At risk of contrast-induced renal failure • Allergy to anticoagulation medicine • Life expectancy < 12 month

Parachute Studies Sites Investigational Site Subjects Enrolled* US-IDE-PARACHUTE Geisinger Clinic, Danville, PA 1 The Ohio State University, Columbus, OH 6 Texas Heart Institute, Houston, TX 4 Washington, DC 1 Northwestern University Hospital, Chicago, IL 2 Cardiology Associates, Asheville, NC 1 Gagnon Cardiovascular Institute, Morristown, NJ 1 Dedinje Cardiovascular Institute, Belgrade, Serbia 2 Total 18 OUS-PARACHUTE Dedinje Cardiovascular Institute, Belgrade, Serbia 12 Kerkhoff Klinik Bad Nauheim, Germany 2 Sankt Katharinen Hospital, Frankfurt, Germany 5 Total 19 Grand Total, combined studies 37 * As of 05/19/2009. Only 7 US patients with 6 -month follow-up data

Methods • Device implantation under local anesthesia • 14 F / 16 F trans-femoral sheath • Follow-up: - TTE @1, 3, 6, 9, 12 months and then yearly to 5 years LV-gram (EU) + CT Scan @ 6 months • EU: Aspirin and Clopidogrel for 6 months • US: Anticoagulation (Coumadin) for 6 months

Device Implantation • 70 y. o. male - AMI in 1998, CABG in 1999 • Left ventricular aneurysm, EF 38% • On Aspirin, Carvedilol, Ramipril, Nitro, Lasix • NYHA III DEVICE IN APICAL POSITION

Device Implantation BALLOON INFLATION TO EXPAND DEVICE FULL DEPLOYMENT

Device Implantation FINAL ANGIO

CT Scan before 6 months

LVEDP (OUS only), Paired Data, n= 8 P<0. 02

LVEDV-Index (ml/m 2) N = 21 P<0. 001

LVESV-Index (ml/m 2) N = 21 P<0. 001

EF (%) N = 21 P<0. 001

NYHA N = 21 P<0. 01

Minnesota LWHFQ Score N = 21 P<0. 01

6 -minute Walk Test (m) N = 21 P<0. 02

Serious Adverse Events up to 24 mo • 1 Early death - Sepsis from undiagnosed peri-anal abscess Device removed - culture negative for infection Myocardial infarction, non-device related • 2 late deaths, 5 months post-implant - 1 ventricular dysrhythmia - 1 pump failure • Minor stroke, 14 months post-implant - Bilateral carotid artery disease, full recovery • 2 TIA - 9 months post-implant (due to paroxysmal AF? ) - 24 -hour post-implant (patient with severe poly-vascular disease) • Device misplacement / dislodgement - 1 surgical removal, 1 catheter retrieval • Groin complications - 1 femoral artery pseudo-aneurysm surgically repaired - 1 bleeding requiring re-hospitalization • 1 Deep vein thrombosis • Worsening heart failure during FU - 11 episodes in 6 patients (1 Heart transplantation after 6 -months) • Hospitalization for syncope, after 2 years - II degree heart block, Ventricular Dyssynchrony and Intermittent AF

The VPD Implant • Is the first catheter-based system to treat LV wall motion abnormalities • Implant procedure seems to be safe up to 24 months • 6 month data show improved functional and hemodynamic outcome • A randomized trial is planned