Medtronic Medtronic CardioVascular CardioVascular

Interventional PipelineInterventional Pipeline

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DISCLOSURESDISCLOSURES

Professor Martin T RothmanProfessor Martin T RothmanVP Medical Affairs, Coronary & PeripheralVP Medical Affairs, Coronary & Peripheral

Santa Rosa, CaliforniaSanta Rosa, California&&

Professor of Interventional Cardiology, Professor of Interventional Cardiology, Barts and the London NHS TrustBarts and the London NHS Trust

• Never prepared so long in advance of talkNever prepared so long in advance of talk• Never had to have slides approvedNever had to have slides approved• Never spoken as a company employee beforeNever spoken as a company employee before

NEXT GENERATION STENT PLATFORM NEXT GENERATION STENT PLATFORM

Development targetDevelopment targetNew platform manufacturing technology for enhanced deliverability and New platform manufacturing technology for enhanced deliverability and conformabilityconformability– Particularly for tortuous, long and small vesselsParticularly for tortuous, long and small vessels

Potential future platform for new BMS and future generation DESPotential future platform for new BMS and future generation DES– Potential utilization of new alloysPotential utilization of new alloys

Innovation concept = helical designInnovation concept = helical designContinuous sinusoidal interlocked pattern Continuous sinusoidal interlocked pattern Thin rounded strutsThin rounded struts

Early prototype results*Early prototype results*Improved flexibility vs. modular technologyImproved flexibility vs. modular technologyLower crossing profileLower crossing profileImproved deliverability in tortuous vesselsImproved deliverability in tortuous vessels

7* In animal studies

• 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 FILLED STENT CONCEPTDRUG FILLED STENT CONCEPT

Drug elution controlled by Drug elution controlled by organic diffusion organic diffusion physicsphysics

Drug fills hollow structureDrug fills hollow structureExits through holesExits through holes

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POLYMERLESS NANOTECHNOLOGYPOLYMERLESS NANOTECHNOLOGY

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

NSMBare

metal

*Demonstrated in in vitro studies

Nanoporous surface modification adherence and growth of cultured human endothelial cells as compared to bare metal (4-days)*

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BIOABSORBABLE POLYMER SURFACESBIOABSORBABLE 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

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Bovine Pericardium Valve

Self expanding Nitinol frame

Self positioning technology

Trans-apical

Patented Venturi design optimizes hemodynamics

Porcine Pericardium Valve

Self expanding multi-level Nitinol frame

Partially repositionable

18Fr Delivery System

ENGAGER TMCOREVALVE®

TRANSCATHETER TRANSCATHETER AORTIC VALVE TECHNOLOGY AORTIC VALVE TECHNOLOGY

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TRANSCATHETER TRANSCATHETER AORTIC VALVE TECHNOLOGY AORTIC VALVE TECHNOLOGY

• 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 Hyperactivity of the renal sympathetic nerves plays a key role in hypertensionnerves plays a key role in hypertension

RESISTANT HYPERTENSIONRESISTANT HYPERTENSION CATHETER BASED TECHNOLOGIES CATHETER BASED TECHNOLOGIES

Repeated measures ANOVA: P<0.001 for SBP & DBPP<0.00001 vs. baseline for each SBP & DBP

Change inBlood

Pressure(mmHg)

89% Responder Rate

• 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

ERECTILE DYSFUNCTIONERECTILE DYSFUNCTION CATHETER BASED TECHNOLOGIESCATHETER BASED TECHNOLOGIES

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…Not bad for 9 days in new job…

Medtronic Medtronic CardioVascular CardioVascular

Interventional PipelineInterventional Pipeline