Boston Scientific Corporation 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 (SCA), yet leaves the heart and vasculature untouched, minimizing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators (TV-ICDs).
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.
"We are excited to offer the second generation S-ICD System to physicians as a compelling treatment option for the majority of ICD-indicated patients. With the already established robust safety and efficacy clinical data, the EMBLEM S-ICD System is designed to enhance patient comfort, while still providing a less invasive treatment for patients at risk of cardiac arrest," said Kenneth Stein, M.D., Chief Medical Officer, Rhythm Management, Boston Scientific.