Single-chamber leadless pacemaker receives FDA approval to treat slow heart rhythms
Abbott announced that the FDA has approved its Aveir VR single-chamber leadless pacemaker for the treatment of bradycardia, according to a company press release.
The Aveir VR is implanted directly in the right ventricle via a minimally invasive procedure. The device features a unique mapping capability to determine correct placement before final implantation. It also features increased projected battery life that can last up to two times longer than other currently commercially available leadless pacemakers, according to the release.
The Aveir VR is the only leadless pacemaker designed to be retrieved, according to the release.
“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,” Randel Woodgrift, senior vice president of cardiac rhythm management at Abbott, said in the release.
Approval was supported by data from the LEADLESS II phase 2 investigational device exemption study. According to results presented at the annual Scientific Sessions of the Asia Pacific Heart Rhythm Society in November 2021 and published in the Journal of the American College of Cardiology: Clinical Electrophysiology, the device met its prespecified primary endpoints.
“The Aveir leadless pacemaker offers an exciting option for the treatment of people with cardiac arrhythmias. Leadless pacemakers address known complications associated with traditional pacemakers. In addition, the Aveir leadless pacemaker brings unique innovations we’ve been seeking, such as the ability to ensure electrical performance before we commit to placement,” Rahul Doshi, MD, director of electrophysiology at Honor Health, said in the release. “Abbott’s leadless pacemaker addresses the need for a single-chamber device that accommodates any therapy path for a patient through Aveir’s retrieval capability and extended battery longevity.”
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