The FDA has granted Boston Scientific Corporation regulatory approval for its S-ICD System, a commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

The S-ICD System is designed to provide the same protection from sudden cardiac arrest as transvenous ICDs.  The system has two main components: (1) the pulse generator, which powers the system, monitors heart activity, and delivers a shock if needed, and (2) the electrode, which enables the device to sense the cardiac rhythm and deliver shocks when necessary.  Both components are implanted just under the skin-the generator at the side of the chest, and the electrode beside the breastbone.  Unlike transvenous ICDs, the heart and blood vessels remain untouched.  Implantation with the S-ICD System is straightforward using anatomical landmarks, without the need for fluoroscopy.  Fluoroscopy is required for implanting the leads attached to transvenous ICD systems.

Approval of the 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 of the study.

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

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