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Medtronic CardioVascular Interventional Pipeline. 1. DISCLOSURES. Professor Martin T Rothman VP Medical Affairs, Coronary & Peripheral Santa Rosa, California & Professor of Interventional Cardiology, Barts and the London NHS Trust. Never prepared so long in advance of talk
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DISCLOSURES Professor Martin T Rothman VP Medical Affairs, Coronary & Peripheral Santa Rosa, California & Professor of Interventional Cardiology, Barts and the London NHS Trust • Never prepared so long in advance of talk • Never had to have slides approved • Never spoken as a company employee before
NEXT GENERATION STENT PLATFORM Development target New platform manufacturing technology for enhanced deliverability and conformability Particularly for tortuous, long and small vessels Potential future platform for new BMS and future generation DES Potential utilization of new alloys Innovation concept = helical design Continuous sinusoidal interlocked pattern Thin rounded struts Early prototype results* Improved flexibility vs. modular technology Lower crossing profile Improved deliverability in tortuous vessels * In animal studies 7
DRUG FILLED STENT CONCEPT • Development target • No abluminal polymer – essentially a BMS surface • Addressing issues of • Polymer biocompatibility • Inflammation upon polymer degradation • Surface coating durability • Innovation concept • Drug filled stent concept (DFS) • Early prototype results • Hole dimension allow for • Controlled • Prolonged • Tailored elution profiles Drug fills hollow structure Exits through holes Drug elution controlled by organic diffusion physics 8
POLYMERLESS NANOTECHNOLOGY NSM Bare metal • Development targets • Rapid + ‘healthy’ endothelialization* • Significant inhibition of restenosis / cell • proliferation without the use of a polymer • Innovation concept • Porous surface - for non-polymeric • drug release • Pro-healing surface • Challenges • Ability to fine tune elution and obtain desired • efficacy Nanoporous surface modification adherence and growth of cultured human endothelial cells as compared to bare metal (4-days)* 9 *Demonstrated in in vitro studies
BIOABSORBABLE POLYMER SURFACES • Development Targets • Coating and drug elution • characteristics to ensure efficacy • Biocompatibility during biodegradation • Rapid enough degradation to reduce anti- • platelet therapy • Innovation concept • Bioabsorbable polymer • Challenges • Degrading without any significant inflammatory response over a reasonable time to ensure good biocompatibility and safety 10
TRANSCATHETER AORTIC VALVE TECHNOLOGY COREVALVE® ENGAGER TM • Porcine Pericardium Valve • Self expanding multi-level Nitinol frame • Partially repositionable • 18Fr Delivery System • Bovine Pericardium Valve • Self expanding Nitinol frame • Self positioning technology • Trans-apical • Patented Venturi design optimizes hemodynamics 12
TRANSCATHETER AORTIC VALVE TECHNOLOGY
RESISTANT HYPERTENSION CATHETER BASED TECHNOLOGIES Change in Blood Pressure (mmHg) 89% Responder Rate Repeated measures ANOVA: P<0.001 for SBP & DBP P<0.00001 vs. baseline for each SBP & DBP • Catheter-based procedure using standard interventional techniques • RF energy delivered through the renal artery wall to denervate the renal nerves • Pilot study suggests significant and sustained reductions in blood pressure in patients with resistant hypertension Hyperactivity of the renal sympathetic nerves plays a key role in hypertension
ERECTILE DYSFUNCTIONCATHETER BASED TECHNOLOGIES • Erectile dysfunction (ED) - largely a vascular disease • Significant portion of ED caused by inadequate blood flow • 75% of men with CAD have ED • ED shown to predate CAD by ~3 years • Despite drug therapy - ED still a significant unmet medical need • Many patients don’t optimally respond to current drugs (PDE5i) • Medtronic pioneering interventional ED approach - co-operation with interventional cardiologists and urologists= stenting of pelvic arteries • - ZEN (feasibility) study - 50 patients/10 USA centers • - Results expected by 2011 • - Study will add insight into proper patient selection ZEN (Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males with Sub-Optimal Response to PDE5 Inhibitors)
Not bad for 9 days in new job… Medtronic CardioVascular Interventional Pipeline