In November 2021, the Abbott Park, Illinois-based company reported results from an FDA investigational device exemption (IDE) study that showed that Aveir met pre-specified primary endpoints in patients with certain abnormal heart rhythms, suggesting that, if approved, Aveir could aid those who require the use of a pacemaker to treat slow heart rhythms.
Abbott’s Aveir is its answer to Medtronic’s Micra leadless pacemakers, which won initial FDA approval in 2016.
Aveir is implanted directly into the heart’s right ventricle in a minimally invasive procedure. According to a news release, Abbott designed Aveir VR with a unique mapping capability that allows physicians to measure electrical signals within the heart and determine the correct placement of the device before final implantation.
The leadless pacemaker has an increased projected battery life that Abbott said can last up to two times longer than other currently available leadless pacemakers. The company also said Aveir VR represents the only leadless pacemaker designed to be retrieved if therapy needs evolve.
“The Aveir VR leadless pacemaker was designed to make the implantation and retrieval processes as seamless as possible for physicians and provide improvements over existing options,” Abbott SVP of Cardiac Rhythm Management Randel Woodgrift said in the release. “Our goal is to continue to build on the success of Aveir to provide more first-of-their-kind products in the future, revolutionizing how abnormal heart rhythms are treated.”