Full Press Release Details
MARLBOROUGH, Mass. , April 20, 2016 /PRNewswire/ -- Boston Scientific (NYSE: BSX ) has received CE Mark approval for the new EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted EMBLEM S-ICD Systems.
The EMBLEM S-ICD Systems are treatment options for patients at risk of sudden cardiac arrest (SCA) that leave the heart and vasculature untouched, reducing the risk of complications associated with transvenous implantable cardioverter-defibrillators (TV-ICDs). Initial market release of the new EMBLEM MRI S-ICD System has begun in a small number of European centers with a broad European launch scheduled for early this summer.
In Europe , the EMBLEM MRI S-ICD System joins the growing family of ImageReady™ MR-conditional devices, all of which are labeled safe for use in a magnetic resonance image setting when conditions of use are met. Patients receiving the EMBLEM MRI S-ICD System as well as patients who previously were implanted with an EMBLEM S-ICD System are now able to undergo full-body MR scans safely in 1.5 Tesla environments when conditions of use are met.
"These approvals give reassurance to physicians and their patients that they have access to any future MR scan needs, and underscores the Boston Scientific commitment to gain MR-conditional labeling on high-voltage devices that are being implanted today," said Kenneth Stein , M.D., chief medical officer, Rhythm Management, Boston Scientific. "Further, the EMBLEM S-ICD System is a compelling treatment option for the majority of ICD-indicated patients that provides protection from cardiac arrest without invading the heart and blood vessels."
The company is actively pursuing U.S. Food and Drug Administration (FDA) approval of the EMBLEM MRI S-ICD System as well as MR-conditional labeling for previously implanted EMBLEM S-ICD Systems. Additionally, the global ENABLE MRI study, initiated earlier this year, is intended to support FDA approval for MR-conditional labeling across the company's currently approved ICD and cardiac resynchronization therapy systems.
For more information on the EMBLEM S-ICD Systems visit www.sicdsystem.com .
In the U.S., the EMBLEM MRI S-ICD System is not available for sale.
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 www.bostonscientific.com and connect on Twitter and Facebook .
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CONTACTS: U.S. Media: Laura Aumann Boston Scientific Corporation (651) 582-4251 (office) [email protected]
European Media: Simonetta Balbi 39 010 6060281 (office) Boston Scientific Corporation [email protected]
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SOURCE Boston Scientific Corporation