Subcutaneous Implantable Cardiac Defibrillator FDA Approved

Boston Scientific has received FDA approval for its S-ICD System, the world’s first and only commercially available subcutaneous implantable defibrillator for treatment of patients at risk for sudden cardiac arrest. 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. Boston Scientific acquired the S-ICD System earlier this year by acquisition of Cameron Health.

Conventional ICD systems are also implanted subcutaneously, but have an electrode lead that runs transvenously to the heart. With the S-ICD system, both the pulse generator and the electrode are implanted subcutaneously on the chest, eliminating some of the complexity and complications associated with the conventional implant procedure. From the press release:

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 (an x-ray procedure that makes it possible to see internal organs in motion). 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, and results were presented earlier this year at the Heart Rhythm Society 33rd Annual Scientific Sessions. 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 received CE Mark in 2009 and has been implanted more than 1400 times since then. In the United States, Boston Scientific expects to begin a phased launch of the S-ICD system that will expand over time. The company believes it will be the only one offering an FDA-approved subcutaneous implantable defibrillator for at least the next several years.

Flashbacks: Subcutaneous Implantable Cardiac Defibrillators; EU Issues OK for Minimally Invasive Subcutaneous Implantable Defibrillator; Entirely Subcutaneous Implantable Cardioverter-Defibrillator Showing Promise in Clinical Study; Cameron Health’s Leadless Implatable Cardiac Defibrillator Looking to Get FDA Approval

Press release: Boston Scientific Receives FDA Approval of First-in-Class S-ICD System for Patients at Risk of Sudden Cardiac Arrest…

Product page: S-ICD System…