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A leadless pacemaker would address a key downside of the current transvenous system: the weak link between the pacemaker generator and the heart. In addition, the lack of a generator placed in the subcutaneous tissue would avoid pocket hematomas and infections. Recently, interim results from the clinical study of the St. Jude Nanostim leadless pacemaker were favorable (NEJM JW Cardiol Oct 2 2015; [e-pub] and N Engl J Med 2015; 373:1125). Now, a manufacturer-sponsored trial reports that a second leadless pacemaker, the Medtronic Micra, also meets safety and efficacy goals.
The Micra study had a design similar to the Nanostim study: 6-month efficacy was assessed for the first 300 implants. Implants continued during follow-up, and these implant…