Abbott announced today the world’s first patient implants of a dual-chamber leadless pacemaker system as part of its AVEIR DR i2i™ pivotal clinical study. Abbott’s “i2i technology” is used to provide beat-by-beat communication between two leadless pacemakers, one positioned in the right ventricle and one positioned in the right atrium to allow for true dual-chamber leadless pacing.
The Aveir DR i2i study is a prospective, multicenter, international, single-arm, pivotal investigational study designed to evaluate the clinical safety and efficacy of the Aveir DR leadless pacemaker in patients who were indicated for a DDD(R) pacemaker. The study plan is to enroll up to 550 patients from up to 80 sites, and all patients will be followed for a minimum of 12 months post-implant.