FDA Approves First Subcutaneous ICD

Reed Miller


September 28, 2012

September 28, 2012 (Silver Spring, Maryland) — As expected, the S-ICD (Cameron Health/Boston Scientific) has become the first subcutaneous implantable cardioverter defibrillator available commercially in the US after the Food and Drug Administration approved a premarket approval application for the device on September 28, 2012 [1].

In April, the FDA's Circulatory System Devices Panel voted seven to one to recommend approval of the S-ICD. The approval is based primarily on the results of a 33-center trial in which over 300 patients were implanted with an S-ICD because they were indicated for an ICD according to class I or II professional guideline recommendations or were getting a replacement for a transvenous ICD. The S-ICD system successfully converted 100% of investigator-induced ventricular fibrillations (VFs), beating the preset objective-performance criteria of 88%.

Over six months of follow-up, the S-ICD detected and recorded 78 spontaneous arrhythmias in 21 patients, all of which were either successfully converted to normal rhythm by the defibrillator or resolved on their own. The most common complications in the study were inappropriate shocks, discomfort, system infection, and electrode movement requiring repositioning. There were eight patient deaths, but none of them were attributable to the device. Overall, over 90% of the patients had no complications at six months.

As reported by heartwire , data from the European EFFORTLESS registry show that inappropriate shocks and other complications with the device become less frequent as electrophysiologists gain more experience with it.

As a condition of approval, the FDA is requiring that Boston Scientific/Cameron Health continue studying the long-term safety and performance of the S-ICD in at least 1616 patients over five years, paying particular attention to potential gender differences in outcomes with the device.