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A subcutaneous implantable cardioverter–defibrillator (ICD) made by Boston Scientific was approved by the FDA in 2012, although it was recalled in 2021. Among the potential advantages of a subcutaneous ICD is avoiding use of an intravenous lead and the related complications of lead failure. Medtronic has developed a unique subcutaneous ICD that also incorporates a single lead — implanted under the sternum — that can pace patients out of ventricular tachycardia (but not bradycardia). The company funded a multinational, prospective, single-arm, nonrandomized, premarket study of the device (NCT04060680).
Of 356 enrolled patients, 316 had an implant attempt; 315 were successful. In all, 302 patients were inducible, defibrillation was successful …