A GLIMPSE INTO THE FUTURE
DR. CARMEN WALBERT MD
MEDICAL DIRECTOR CARDIOVASCULAR
MEDTRONIC EUROPE
DISCLOSURES
DR. CARMEN WALBERT MD
MEDICAL DIRECTOR CARDIOVASCULAR
MEDTRONIC EUROPE
A GLIMPSE INTO …
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MEDTRONIC’s cardio-vascular portfolio
Drug filled stent concept
Drug eluting balloon
Resistant hypertension and renal sympathetic
radiofrequency ablation
• Erectile dysfunction and stenting of pudendal
artery
• Leadless pacemakers
FUTURE
“As for the future,
your task is not to
foresee it, but to
enable it.”
(Antoine de Saint-Exupery)
MEDTRONIC PORTFOLIO OF FUTURE
INTERVENTIONAL THERAPIES
CONTINUOUS SINUSOID TECHNOLOGY
PLATFORM ENABLING TECHNOLOGY
Wire form allows
multitude of new
options
BARE METAL STENTS
Integrity
•
1st
generation
DRUG-ELUTING STENTS
DRUG-FILLED STENT
Resolute
Integrity
• ~91μm
Core Wire
(S10)
New Alloys
Platforms for next
generation DES
IN.PACT DRUG ELUTING BALLOON
DEB: short term elution for long term effect
IN.PACT: Medtronic-Invatec DEB balloon line
Freepac: Proprietary hydrophilic drug coating formulation
Drug: Paclitaxel (3g /mm2 balloon surface)
Paclitaxel + Hydrophilic Spacer: Urea (100% natural component)
Freepac 
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Separates Paclitaxel molecules
Balances hydrophilic and
lipophilic properties
Facilitates Paclitaxel elution into
the vessel wall
HYPERTENSION - MAJOR GLOBAL PUBLIC
HEALTH CONCERN
•
3
Around 30 – 40% of the adult population
in the
developed world, suffer from hypertension. 1
– Hypertension estimated to cause 4.5% of current global disease
burden.2
– Hypertension – number one risk factor for premature death
The
statistics speak
volumes, but physicians do not treat populations.
1
worldwide
They treat patients. The human cost is high.
•
Globally the estimated annual healthcare expenditure
directly related to hypertension is approximately 500
billion $. 3
1. Mathers C. et al., WHO 2009
2. 2003 WHO/ISH statement on management of hypertension
3. Lawes C.M. et al., Lancet 2008; 371: 1513 - 1518
THE HUMAN COST OF UNCONTROLLED
HYPERTENSION (I)
• Attributable to arterial hypertension
– 54 % of strokes
– 47% of ischemic heart disease
Lawes et al., Lancet 2008; 371:1513 - 1518
THE HUMAN COST OF UNCONTROLLED
HYPERTENSION (II)
Among stroke patients:
J Rendon et al., J Hypertens 2008; 26 (suppl.4) 1-14
RESISTANT ARTERIAL HYPERTENSION
• Resistant hypertension = when a therapeutic
plan that has included attention to lifestyle measures and the prescription
of at least three drugs (including a diuretic) in adequate doses has
failed to lower systolic and diastolic blood
pressure to goal.1
• The % of patients achieving adequate blood
pressure control to guideline target values
remains low.
– In the region of 30% even among those who
are diagnosed and treated. 2
1. 2007 Guidelines for the management of arterial hypertension, European Heart Journal (2007) 28, 1462–1536
2. Kearney PM et al., Worldwide prevalence of hypertension: a systematic review. J Hypertens 2004; 22:11-19
RESISTANT HYPERTENSION
CATHETER BASED TECHNOLOGIES
Concept Description
• Catheter-based procedure using standard
interventional techniques
• RF energy delivered through the renal
artery wall to denervate the renal nerves
RESULTS SYMPLICITY HTN 1 *
Hyperactivity of the renal
sympathetic nerves plays a
key role in hypertension
* Trial performed with SYMPLICITY CATHETER SYSTEM A device developed by Ardian
Krum, Henry. “Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proofof-principle cohort study, Lancet, doi:10.1016/S0140-6736(09)60566-3. April 2009; updated @ PCR 10 (May 2010)
RESISTANT HYPERTENSION
CATHETER BASED TECHNOLOGIES
Concept Description
• Catheter-based procedure using standard
interventional techniques
• RF energy delivered through the renal
artery wall to denervate the renal nerves
The trasaction is subject to customary closing conditions, including
U.S. and foreign regulatory clearances
RESULTS SYMPLICITY HTN 2 *
Hyperactivity of the renal
sympathetic nerves plays a
key role in hypertension
* Trial performed with SYMPLICITY CATHETER SYSTEM
A device developed by Ardian
,
Symplicity HTN-2 Investigators Lancet Published online November
17, 2010 DOI:10.1016/S0140-6736(10)62039-9
A PATIENT WITH RESISTANT
HYPERTENSION
ERECTILE DYSFUNCTION
LARGELY A VASCULAR DISEASE
• Erectile
dysfunction
Largely a
vascular disease
– Significant portion
of ED caused by
inadequate blood
flow
– 75% of men with
CAD have ED 1
– ED shown to
predate CAD by ~3
years 1
1. JH Rogers TCT 2010
ERECTILE DYSFUNCTION
CATHETER BASED TECHNOLOGIES
• Despite drug therapy - ED still a
significant unmet medical need
– Many patients don’t optimally respond to
current drugs (PDE5i)
– Medtronic-sponsored PANPI study showed
correlation between poor PDE5i response
and disease in internal pudendal artery
• FIM (ZEN trial) - initiated in the USA
– Safety and feasibility study for stenting
treatment of refractory ED
– Close collaboration with urologists and IC
– Planning to enroll 50 patients / 20 sites
– If successful, larger pivotal trial to follow
ZEN (Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in
Males with Sub-Optimal Response to PDE5 Inhibitors) 1. O’Connell et al., based on the
Massachusetts Male Aging Study on Impotence. Exp Gerontol. 2004 Jul;39(7):975-84
PACEMAKERS THROUGH THE YEARS
DIME
5800
5858
First External Pacemaker
Diameter
= 17,91 mm
Pediatric
Asynchronous
First Implantable Pacemaker
PG
Thickness = 1,35 mm
1958
Activitrax®
1986
1970
1960
Synergist™
1989
Elite™
1991
Kappa®
1998
Adapta™
2006
First
Leadless
Pacemaker
2015 est
PERCUTANEOUS LEADLESS
MICRO-PACEMAKER
Steerable Sheath/Catheter
Miniaturized, leadless
VVI/R pacer with basic
therapy and diagnostic
set
KEY POTENTIAL BENEFITS
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Less-invasive, easier to use, more cost effective
Less implanted hardware ("invisible")
Faster, simpler procedure
(totally percutaneous, no surgery)
Fewer complications (no lead or device pocket)
Shorter hospital stay
Easier follow-up
MRI safe
THANK YOU
‘ These days people seek
knowledge, not wisdom.
Knowledge is of the past,
wisdom is of the future.
(Vernon Cooper)