FDA Clears First Subcutaneous ICD

First-in-class S-ICD System designed for easier implantation in patients at risk of sudden cardiac arrest


October 8, 2012
Cameron Health, Boston Scientific S-ICD subcutaneous implantable defibrillator

The S-ICD System is the world's first subcutaneous implantable cardioverter 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 implantable lead to be placed inside the heart. This leaves the heart and blood vessels untouched, offering patients an alternative to transvenous ICDs, which require leads to be placed in the heart itself. Approval of the S-ICD System was based on data from a 330-patient, prospective, nonrandomized, multicenter clinical study, which evaluated the safety and effectiveness of the system in patients at risk of SCA. The system met the primary endpoints of the study, and results were presented at the Heart Rhythm Society 33rd Annual Scientific Sessions in 2012. The study results support that the S-ICD System is an important new treatment option for a wide range of primary and secondary prevention patients. 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, eliminating patient X-ray exposure. Fluoroscopy is required for implanting the leads attached to transvenous ICD systems. 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. The company acquired the S-ICD System earlier in 2012 when it completed the acquisition of Cameron Health Inc. The S-ICD System received CE mark in 2009 and is commercially available in many countries in Europe as well as in New Zealand.  To date, more than 1,400 devices have been implanted in patients around the world. 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 antitachycardia pacing. The U.S. Food and Drug Administration (FDA) granted Boston Scientific Corp. regulatory approval for its S-ICD System in September 2012. For more information: www.bostonscientific.com