Boston Scientific Corporation

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.

Please CLICK HERE [http://www.bostonscientific.com/en-EU/news/newsroom-uk/heart-rhythm-disorder.html] for multimedia, images and other information.

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 [http://www.facebook.com/bostonscientific].

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans, markets for our products, clinical trials and data impact, product performance and impact, and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A - Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

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
 

Contact:

PR and Corporate Communication Europe: Boston Scientific
Corporation, +39-3387936422 (mobile), +39-0106060281 (direct),
Balbis@bsci.com

Original-Content von: Boston Scientific Corporation, übermittelt durch news aktuell

Weitere Meldungen: Boston Scientific Corporation

Das könnte Sie auch interessieren: