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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 …. MEDTRONIC’s cardio-vascular portfolio
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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 … • 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)
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
IN.PACT:Medtronic-Invatec DEB balloon line Freepac: Proprietary hydrophilic drug coating formulation Drug: Paclitaxel (3g /mm2 balloon surface) Paclitaxel + Hydrophilic Spacer: Urea (100% natural component) 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
3 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.
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
RESULTS SYMPLICITY HTN 1 * 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, doi:10.1016/S0140-6736(09)60566-3. April 2009; updated @ PCR 10 (May 2010)
The trasaction is subject to customary closing conditions, including U.S. and foreign regulatory clearances RESULTS SYMPLICITY HTN 2 * 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 DOI:10.1016/S0140-6736(10)62039-9
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
ERECTILE DYSFUNCTIONCATHETER 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
DIME Diameter = 17,91 mm Thickness = 1,35 mm PACEMAKERS THROUGH THE YEARS 5800 5858 First External Pacemaker First Implantable Pacemaker Pediatric Asynchronous PG 1958 1970 1960 Synergist™ Elite™ Kappa® Adapta™ Activitrax® First LeadlessPacemaker 2015 est 1986 1989 1991 1998 2006
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
THANK YOU ‘ These days people seek knowledge, not wisdom. Knowledge is of the past, wisdom is of the future.(Vernon Cooper)