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# Abbott’s Leadless Pacemaker Approved for Slow Hearts
- URL: https://www.fdaweb.com/abbotts-leadless-pacemaker-approved-for-slow-hearts/
- Published: 2022-04-04T12:00:00.000Z
- Updated: 2026-09-14T17:39:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151512

FDA has approved Abbott’s Aveir VR single-chamber leadless pacemaker for treating patients with slow heart rhythms. The device is implanted directly inside the heart’s right ventricle and the leadless pacemaker does not require an incision in the chest or cardiac leads to deliver therapy, according to the company.

Abbott says the device has a mapping capability designed to allow physicians to measure electrical signals within the heart and determine the correct implant placement. It also has an increased projected battery life that can be up to two times longer than current leadless pacemakers. And it says it is the only leadless pacemaker designed to be retrieved if therapy needs evolve.

Approval is based on data from the global LEADLESS II Phase 2 study evaluating Aveir VR in patients with certain abnormal heart rhythms. It showed the device met its pre-specified primary endpoints, according to Abbott. The findings from the study were d [published](https://c212.net/c/link/?t=0&l=en&o=3492287-1&h=19792052&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3357086-1%26h%3D2056533051%26u%3Dhttps%253A%252F%252Fwww.jacc.org%252Fdoi%252Fpdf%252F10.1016%252Fj.jacep.2021.11.002%26a%3Dsimultaneously%2Bpublished&a=simultaneously+published&ref=fdaweb.com) in the *Journal of the American College of Cardiology: Clinical Electrophysiology*.