Last year the FDA approved Boston Scientific’s subcutaneous ICD, the first ICD that can defibrillate the heart without using leads threaded to the heart through the blood vessels. Those leads are the source of many sophisticated pacing features in today’s ICDs, but they are also the main source of ICD-related complications, and, in several well-publicized incidents, have forced the FDA and ICD companies to initiate recalls. Now a prominent cardiologist writes that the S-ICD poses an “existential crisis” for previous generations of ICDs.
FDA approval of the S-ICD was based on a pivotal trial designed to assess the device’s safety and effectiveness. Results of the trial have now been published in Circulation. In this nonrandomized trial, the S-ICD was successfully implanted in 314 patients out of 321 in whom the implnantation was attempted.
The S-ICD easily met the prespecified primary safety and efficacy endpoints: