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Abbott’s AVEIR™ VR Ventricular Leadless Pacemaker Proves Effective in Clinical Study

Abbott Cardiac Rhythm Management | September 9, 2022

The effectiveness of Abbott’s AVEIR™ VR Ventricular Leadless Pacemaker (LP), which recently earned both FDA and CMS approval, was evaluated during a clinical study that proved both the safety and efficacy of this trailblazing device¹. 

The LEADLESS II–Phase 2 Investigational Device Exemption (IDE) Study evaluated the clinical safety and efficacy of the AVEIR VR LP in patients who were indicated for a VVI(R)—or ventricular demand pacing—pacemaker. People who experience slower-than-normal heart rates may receive a pacemaker to restore a more normal heart rate, and VVI(R) pacemakers are designed to stimulate the heart only if the heart rate falls below a set level. 

Key Features and Design of AVEIR VR LP

Leadless pacemakers, unlike traditional pacemakers, do not require an incision in the chest to implant the device or insulated wires—known as cardiac leads—to deliver energy to the heart.

Instead, leadless pacemakers are implanted directly into the heart's right ventricle via a minimally invasive procedure, requiring no cardiac leads to deliver therapy.

Abbott’s AVEIR VR LP was designed with key design features:

• Standard transvenous pacemaker battery chemistry (lithium carbon-monofluoride) with high capacity (243 mAh), which offers at least 1.7x the projected longevity of current VR leadless pacemakers based on ISO standard settings^2,3*
• A solid docking button that enables for chronic retrieval with a dedicated retrieval catheter
• An upgradeable platform to later support a dual chamber pacing system when patient therapy need evolves

LEADLESS II IDE Study Focus and Efficacy Evaluation

The Leadless II IDE study was a global, prospective, non-randomized, multicenter study, approved by the Food and Drug Administration (FDA), in which all patients were followed for six weeks post-implant to evaluate potentially serious adverse device effects.

Data from the study evaluated AVEIR VR LP in patients with certain abnormal heart rhythms. The data shows that AVEIR VR LP met its pre-specified primary endpoints and suggests that the device offers benefits for patients who require the use of a pacemaker to treat slow heart rhythms.

During the study, efficacy was measured as both acceptable pacing capture threshold (≤ 2.0 V at 0.4 msec) and sensing amplitude (R wave ≥ 5.0 mV, or a value equal to or greater than the value at implantation).

The study enrolled 200 patients across 43 sites in the United States, Canada, and Europe between November 2020 and June 2021, with a mean follow-up of 3.92 ± 1.87 subject-months. The mean age at enrollment was 75.6 ± 11.3 years, and 62.5% of the participants were male.

LEADLESS II IDE Study Result Highlights

Implant Success

• Implant success was 98% (196 of 200) with 0 dislodgments.
• Of the successful implants, 83.2% (163 of 196) did not require repositioning, and 96.4 required 1 or less repositioning (189 of 196).
• The low repositioning rate was attributed to AVEIR VR LP’s electrical mapping capability prior to LP fixation.

Primary Safety Endpoint

The primary safety endpoint was freedom from serious adverse device effects (also referred to as complications) through six weeks of follow-up. An independent Clinical Events Committee adjudicated adverse events.

• The rates of safety and efficacy endpoints were compared with performance goals (on the basis of historical data) of 86% and 85%, respectively.
• The primary safety end point was met in 190 of 198 evaluable participants (96.0%; 95% CI: 92.2%-98.2%).

Primary Efficacy EndPoint

• The primary efficacy endpoint was met in 96% of evaluated participants when using a composite score of acceptable pacing thresholds (#2.0 V at 0.4 ms) and R-wave amplitudes ($5.0 mV or an equal or greater value at implantation) through six weeks of follow-up.
• Efficacy endpoint based on pacing thresholds only was 98.0% (184 of 196).

AVEIR VR LP uses some of the most advanced technologies to keep hearts beating more regularly. Find more information on product features, how it works and support clinical data.

*Battery longevity estimates based on projections derived from published technical specifications and the ISO standard settings

™ Indicates a trademark of the Abbott group of companies.

^‡ Indicates a third-party trademark, which is property of its respective owner.

References

1. Reddy V, Exner D, Doshi R, et al. Primary Results on Safety and Efficacy From the LEADLESS II–Phase 2 Worldwide Clinical Trial. J Am Coll Cardiol EP. 2022 Jan, 8 (1) 115–117. https://doi.org/10.1016/j.jacep.2021.11.002
2. AVEIR™ VR Leadless Pacemaker and Delivery Catheter IFU. ARTEN600175956
3. Micra‡ VR IFU M991010A001 REV. B