Medtronic CardioVascular Interventional Pipeline 1.

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Presentation transcript:

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 Never prepared so long in advance of talk Never had to have slides approved Never had to have slides approved Never spoken as a company employee before 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 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 CONCEPT Drug elution controlled by organic diffusion physics Drug fills hollow structure Exits through holes 8

POLYMERLESS 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 NSM Bare metal *Demonstrated in in vitro studies Nanoporous surface modification adherence and growth of cultured human endothelial cells as compared to bare metal (4-days)* 9

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

  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 TM COREVALVE ® TRANSCATHETER AORTIC VALVE TECHNOLOGY 12

TRANSCATHETER 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 nerves plays a key role in hypertension RESISTANT HYPERTENSION CATHETER BASED TECHNOLOGIES Repeated measures ANOVA: P<0.001 for SBP & DBP P< vs. baseline for each SBP & DBP Change in Blood 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 Study will add insight into proper patient selection ERECTILE DYSFUNCTION CATHETER 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… Medtronic CardioVascular Interventional Pipeline