Boston Scientific EMBLEM™ S-ICD System named most innovative product at EHRA EUROPACE-CARDIOSTIM 2015
The new generation of subcutaneous defibrillators selected as most innovative in the field of cardiac electrophysiology.
MILAN, Italy, June 23, 2014 – Attendees of EHRA EUROPACE-CARDIOSTIM 2015, a global medical conference held recently in Milan, Italy, have selected the EMBLEM™ S-ICD System as the most innovative product in the sector of cardiac electrophysiology (EP) for patient care improvement.
An international panel of experts, scientists and physicians, gathered as a jury to review the competing products, discuss their added-value and choose the most innovative ones.
The EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) leaves the heart and vasculature untouched, providing protection for patients at risk for sudden cardiac death (SCD) while avoiding complications associated with transvenous implants and leads.
“We are very proud of this recognition which shows the interest and appreciation of the EMBLEM™ S-ICD among the EP community, and encourage our engagement in this area” said Pierre Chauvineau, vice president Europe, Rhythm Management, Boston Scientific. “This Cardiostim Innovation Award validates our view that the System truly represents a revolutionary and ground-breaking new option in this field,” he added.
SCD is the result of a sudden cardiac arrest (SCA), a very serious heart condition that can lead to death if not treated within minutes. About 95 per cent of people who have an SCA die before they reach hospital.[i]
An electrical shock administered to the heart can reset the heart’s rhythm and restore normal blood flow throughout the body. Implantable defibrillator systems are capable of automatically delivering these lifesaving shocks when needed. This is called defibrillation therapy.
The EMBLEM S-ICD System is projected to last more than seven years, 40 per cent more than its previous generation, decreasing the need for change-out procedures.[ii],[iii]
The new design is 20 per cent thinner, improving the implant experience and patient comfort, and it is also enabled for use with the LATITUDE™ Remote Patient Management System,[iv] streamlining the follow-up of patients.
The recently published Pooled Data Analysis[v] – 2-year results over 882 patients - showed high efficacy of the S-ICD System in terminating episodes of ventricular tachycardia (VT) and ventricular fibrillation (VF); complication and inappropriate shock rate were reduced consistently with strategic programming and, as operator experience increased, no electrode failure, no S-ICD-related endocarditis or bacteremia occurred.
The first generation of the S-ICD System has been available in the UK and other European Countries since July 2009 and was approved in the United States by the Food and Drug Administration (FDA) in September 2012. It was selected as the most innovative product in the Electrophysiology and Cardiac Techniques sector at Cardiostim 2012. The EMBLEM S-ICD System received CE mark earlier this year and was approved by the Food & Drug Administration (FDA) in March of 2015.
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[i]American Heart Association. Heart Disease and Stroke Statistics – 2014 Update. Circulation. 2014;129:e28-e292.
[ii] PULSE GENERATOR USER'S MANUAL EMBLEM™ S-ICD Mod. A209 - 359279-001 EN EU 2014-06
[iii] SQ-RX® PULSE GENERATOR, A COMPONENT OF THE S-ICD® SYSTEM USER’S MANUAL MODEL 1010 – PN 1021980-10 Rev A 2011/12
[iv] EMBLEM S-ICD Labeling
[v] M Burke et Al., Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator, 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry, J Am Coll Cardiol 2015;65:1605–15