1 October 2012 - Medical devices company Boston Scientific Corporation (NYSE:BSX) reported on Friday the receipt of regulatory approval from the US Food and Drug Administration for its S-ICD System for the treatment of patients at risk for sudden cardiac arrest (SCA).

The company’s S-ICD System is the world’s first and only commercially available subcutaneous implantable defibrillator (S-ICD). The S-ICD System sits entirely just below the skin without the need for thin, insulated wires to be placed into the heart, leaving the heart and blood vessels untouched and offering patients an alternative to transvenous implantable cardioverter defibrillators (ICDs), which require leads to be placed in the heart itself.

This FDA approval of S-ICD System was based on data from a 330-patient, prospective, non-randomized, multicenter clinical study, which evaluated the safety and effectiveness of the system in patients at risk of SCA. The S-ICD System met the primary endpoints and the results were presented at the Heart Rhythm Society 33rd Annual Scientific Sessions early this year.

Boston Scientific Corporation plan to begin a phased launch of the S-ICD System which will expand over time as medical professionals are trained on the safe and effective use of the system.