A GLIMPSE INTO THE FUTURE

1
A GLIMPSE INTO THE FUTURE
DR. CARMEN WALBERT MD MEDICAL DIRECTOR
CARDIOVASCULAR MEDTRONIC
EUROPE
2
DISCLOSURES
DR. CARMEN WALBERT MD MEDICAL DIRECTOR
CARDIOVASCULAR MEDTRONIC
EUROPE
3
A GLIMPSE INTO

• MEDTRONICs 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

4
FUTURE

• As for the future, your task is not to
  foresee it, but to enable it.
• (Antoine de Saint-Exupery)

5
MEDTRONIC PORTFOLIO OF FUTURE INTERVENTIONAL
THERAPIES
6
CONTINUOUS SINUSOID TECHNOLOGY PLATFORM
ENABLING TECHNOLOGY
Wire form allows multitude of
new options
BARE METAL STENTS
DRUG-FILLED STENT
DRUG-ELUTING STENTS

• Integrity
• 1st generation
• 91µm

Resolute Integrity
Core Wire (S10)
Platforms for next generation DES
New Alloys
7
IN.PACT? DRUG ELUTING BALLOON
DEB short term elution for long term effect

• Freepac ?
• Separates Paclitaxel molecules
• Balances hydrophilic and lipophilic properties
• Facilitates Paclitaxel elution into the vessel
  wall

8
HYPERTENSION - MAJOR GLOBAL PUBLIC HEALTH CONCERN

• 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 worldwide 1
• 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 statistics speak volumes, but physicians do
not treat populations. They treat
patients. The human cost is high.
9
THE HUMAN COST OF UNCONTROLLED HYPERTENSION (I)

• Attributable to arterial hypertension
• 54 of strokes
• 47 of ischemic heart disease

Lawes et al., Lancet 2008 3711513 - 1518
10
THE HUMAN COST OF UNCONTROLLED HYPERTENSION (II)
Among stroke patients
J Rendon et al., J Hypertens 2008 26 (suppl.4)
1-14
11
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,
14621536 2. Kearney PM et al., Worldwide
prevalence of hypertension a systematic review.
J Hypertens 2004 2211-19
12
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

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 proof-of-principle cohort
study, Lancet, doi10.1016/S0140-6736(09)60566-3.
April 2009 updated _at_ PCR 10 (May 2010)
13
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

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 DOI10.1016/S0140-6736(10
)62039-9
14
A PATIENT WITH RESISTANT HYPERTENSION
15
ERECTILE DYSFUNCTIONLARGELY 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
16
ERECTILE DYSFUNCTIONCATHETER BASED TECHNOLOGIES

• Despite drug therapy - ED still a significant
  unmet medical need
• Many patients dont 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. OConnell et al., based on the
Massachusetts Male Aging Study on Impotence. Exp
Gerontol. 2004 Jul39(7)975-84
17
PACEMAKERS THROUGH THE YEARS
5800
5858
First External Pacemaker
First Implantable Pacemaker
Pediatric Asynchronous PG
1970
1958
1960
Synergist
Activitrax
Elite
Kappa
Adapta
First LeadlessPacemaker
2015 est
1986
1989
1991
1998
2006
18
PERCUTANEOUS LEADLESSMICRO-PACEMAKER
Steerable Sheath/Catheter
Miniaturized, leadless VVI/R pacer with basic
therapy and diagnostic set

• KEY POTENTIAL BENEFITS
• 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

19
THANK YOU
These days people seek knowledge, not wisdom.
Knowledge is of the past, wisdom is of the
future. (Vernon Cooper)