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.
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