Boston Scientific's EMBLEM(TM) S-ICD System Named Most Innovative Product at EHRA EUROPACE-CARDIOSTIM 2015

Milan (ots/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(TM) 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(TM) 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(TM) 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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sroom-uk/heart-rhythm-disorder.html ] for multimedia, images and
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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
[http://www.bostonscientific.com/en-EU/home.html ] and connect on
Twitter [http://twitter.com/bsc_eu_heart ] and Facebook
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1) American Heart Association. Heart Disease and Stroke Statistics - 2014
Update. Circulation. 2014;129:e28-e292.
2) PULSE GENERATOR USER'S MANUAL EMBLEM(TM) S-ICD Mod. A209 - 359279-001 EN EU
2014-06
3) SQ-RX(R) PULSE GENERATOR, A COMPONENT OF THE S-ICD(R) SYSTEM USER'S MANUAL
MODEL 1010 - PN 1021980-10 Rev A 2011/12
4) EMBLEM S-ICD Labeling
5) 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

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