Transcript Development target No abluminal polymer

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 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
–
–
–
Drug fills hollow structure
Exits through holes
Polymer biocompatibility
Inflammation upon polymer degradation
Surface coating durability
• Innovation concept
– Drug filled stent concept (DFS)
• Early prototype results
– Hole dimension allow for
•
•
•
Drug elution controlled by
organic diffusion physics
8
Controlled
Prolonged
Tailored elution profiles
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
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 antiplatelet 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®
 Porcine Pericardium Valve
 Self expanding multi-level Nitinol frame
 Partially repositionable
 18Fr Delivery System
ENGAGER
TM
 Bovine Pericardium Valve
 Self expanding Nitinol frame
 Self positioning technology
 Trans-apical
 Patented Venturi design optimizes
hemodynamics
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TRANSCATHETER
AORTIC VALVE TECHNOLOGY
RESISTANT HYPERTENSION
CATHETER BASED TECHNOLOGIES
• Catheter-based procedure using
standard interventional techniques
Change in
• RF energy delivered through the renal Blood
Pressure
artery wall to denervate the renal
(mmHg)
nerves
• Pilot study suggests significant and
sustained reductions in blood pressure
in patients with resistant hypertension
89% Responder Rate
Hyperactivity of the renal sympathetic
nerves plays a key role in hypertension
Repeated measures ANOVA: P<0.001 for SBP & DBP
P<0.00001 vs. baseline for each SBP & DBP
ERECTILE DYSFUNCTION
CATHETER 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)
Medtronic
CardioVascular
Interventional Pipeline
Not bad for 9 days in new job…