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Leads are the Achilles heel of pacemakers and implantable defibrillators. Leads not only wear out over time, but provide a portal of entry for infection into the vasculature. Development of a permanent pacemaker without leads has been a goal for decades. Researchers now report interim results from an industry-sponsored clinical trial of the St. Jude Nanostim VVI leadless permanent pacemaker.
There were a total of 526 patients: 300 patients in the primary cohort who were followed for 6 months, and an additional 226 more-recent participants. Of the total cohort, 504 were successfully implanted with the PPM.
In the primary cohort, 270 patients (90%) met the primary outcome of acceptable pacing parameters for 6 months. Serious adverse events occu…