VIDEO: Early success of dual-chamber leadless pacemaker suggests big changes could be on the horizon

The first leadless, dual-chamber pacing system performed very well in the Aveir dual-chamber i2i investigational device exemption (IDE) study presented as a late-breaking trial at the Heart Rhythm Society's (HRS) 2023 annual meeting. The large-scale study to assess the world's first dual-chamber, leadless pacemaker system met its three primary endpoints for safety and performance. 

The new technology may also open up leadless pacing to a much wider patient population. While leadless pacemakers were seen as a big advance over the past decade, they have been limited to single chamber pacing, which is limited to just 10-20 percent of patients who need a pacemaker. About 80% of patients require dual-chamber pacing. If this new pacing system is cleared by the FDA, it would greatly broaden access to leadless technology for all patients.