MILAN, June 23, 2015 /PRNewswire/ --
The new generation
of subcutaneous defibrillators selected as most innovative in the
field of cardiac electrophysiology.
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.[1]
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.[2],[3]
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,[4]
streamlining the follow-up of patients.
The recently published Pooled Data Analysis[5] -
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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About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the
world. As a global medical technology leader for more than 35
years, we advance science for life by providing a broad range of
high performance solutions that address unmet patient needs and
reduce the cost of healthcare. For more information, visit
http://www.bostonscientific.eu and connect on Twitter and
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- American Heart Association. Heart Disease and Stroke Statistics
- 2014 Update. Circulation. 2014;129:e28-e292.
- PULSE GENERATOR USER'S MANUAL EMBLEM™ S-ICD Mod. A209 -
359279-001 EN EU 2014-06
- SQ-RX® PULSE GENERATOR, A COMPONENT OF THE S-ICD® SYSTEM USER'S
MANUAL MODEL 1010 - PN 1021980-10 Rev A 2011/12
- EMBLEM S-ICD Labeling
- 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