Boston Scientific Receives FDA Approval of First-In-Class S-ICD® System for Patients at Risk of Sudden Cardiac Arrest

Boston Scientific Receives FDA Approval of First-In-Class S- ICD® System for Patients at Risk of Sudden Cardiac Arrest PR Newswire NATICK, Massachusetts, October 4, 2012 NATICK, Massachusetts, October 4, 2012 /PRNewswire/ -- S-ICD System is the World's First and Only Commercially Available Completely Subcutaneous Implantable Defibrillator The U.S. Food and Drug Administration has granted Boston Scientific Corporation (NYSE: BSX) regulatory approval for its S-ICD® System, the world's first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). The S-ICD System sits entirely just below the skin without the need for thin, insulated wires -- known as electrodes or 'leads' -- to be placed into the heart. This leaves the heart and blood vessels untouched, offering patients an alternative to transvenous implantable cardioverter defibrillators (ICDs), which require leads to be placed in the heart itself. "The S-ICD System establishes the first new category of cardiac rhythm management devices since the introduction of cardiac resynchronization therapy," said Raul Weiss, M.D., Associate Professor-Clinical, Cardiovascular Medicine at The Ohio State University. "Doctors now have a breakthrough treatment option that provides protection from sudden cardiac arrest without touching the heart.