Successful trial for Micra Transcatheter Pacing System, a leadless pacemaker- Medtronic

The Micra Transcatheter Pacing System, a leadless pacemaker from Medtronic, performed well in a 725-person clinical trial for FDA approval in the US, where Medtronic is competing with St. Jude Medical to market a leadless pacemaker.

96% of patients implanted with the Micra Transcatheter Pacing System had no major complications at 6 months, and the device was successfully implanted in 99.2% of all patients, according to Medtronic, presenting at the annual meeting of the American Heart Association in Orlando.

The complications included cardiac injuries (1.6%), complications at the groin site (0.7%) and pacing issues (0.3%). There were no dislodgements or systematic infections and 0.4% rate of device extraction, repositioning or replacement. In addition, the Micra met its efficacy endpoint, with 98.3% of patients achieving low and stable pacing capture thresholds at 6 months.

Comment: The trial results are highly positive and will be used by Medtronic for an FDA PMA approval in the next fiscal year, beginning May 2016. The device will compete with the Nanostim leadless pacemaker from St.Jude Medical.