WASHINGTON (dpa-AFX) - Boston Scientific Corp (BSX) on Tuesday said it has received FDA and CE Mark approval of the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System.
The EMBLEM S-ICD System is a treatment option that provides protection for patients at risk of sudden cardiac arrest, yet leaves the heart and vasculature untouched, minimizing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators.
The company said a controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May 2015 and subsequent U.S. launch planned for the third quarter of 2015.
The new generation EMBLEM S-ICD System is 19% thinner and is projected to last 40% longer than the previous S-ICD System.
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