FDA approves Abbott’s Aveir leadless pacemaker

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Abbott has announced that the US Food and Drug Administration (FDA) has approved the Aveir single-chamber (VR) leadless pacemaker for the treatment of patients in the US with slow heart rhythms.

The Aveir leadless pacemaker is implanted directly inside the heart’s right ventricle via a minimally invasive procedure to treat slower-than-normal heart rates. Leadless pacemakers do not require an incision in the chest to implant the device or cardiac leads to deliver therapy.

The device has a mapping capability designed to allow physicians to measure electrical signals within the heart and determine the correct placement of the device before final implantation, Abbott says in a press release. The company adds that the device has an increased projected battery life that can be up to two times longer than other currently commercially available leadless pacemakers when using International Organization for Standardization (ISO) standard settings.

“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 have been seeking, such as the ability to ensure electrical performance before we commit to placement,” said Rahul Doshi (Honor Health, Scottsdale, USA). “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.”

This approval is supported by data from the global LEADLESS II phase 2 investigational device exemption (IDE) study evaluating Aveir VR in patients with certain abnormal heart rhythms. The results showed the device met its pre-specified primary endpoints. The findings were presented at the annual Scientific Sessions of the Asia Pacific Heart Rhythm Society (APHRS) in November 2021 and simultaneously published in the Journal of the American College of Cardiology: Clinical Electrophysiology.


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