Abbott receives FDA approval for dual-chamber leadless pacemaker

Abbott announced that the U.S. Food and Drug Administration, FDA, has approved the AVEIR dual chamber leadless pacemaker system, the world’s first dual chamber leadless pacing system that treats people with abnormal or slow heart rhythms. Through Abbott’s proprietary i2i communication technology, AVEIR DR devices provide synchronized or coordinated cardiac pacing between two leadless pacemakers based on the person’s clinical needs. The i2i technology utilizes high-frequency pulses to relay messages via the naturally conductive characteristics of the body’s blood between each leadless pacemaker. Roughly one-tenth the size of a traditional pacemaker, the AVEIR DR leadless pacing system is made up of two devices – the previously-approved AVEIR VR single chamber device, which paces the right ventricle, and the now-approved AVEIR AR single chamber device, which paces the right atrium. “Leadless pacemakers have been limited to a single chamber device because seamless, wireless synchronization of two pacemakers has been an insurmountable engineering challenge – until now,” said Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business. “Our team of dedicated scientists and engineers solved one of medtech’s complex challenges in treating abnormal heart rhythms with the AVEIR pacemaker, a tiny device packed with powerful technology.”