Setting the Pace with 

AVEIRTM Leadless Pacemakers

Single and Dual Chamber Leadless Pacemaker (LP) Systems, only from Abbott

Clinical Evidence

Leadless pacemakers represent a significant advancement in cardiac pacing technology, offering a promising alternative to traditional transvenous pacemakers.

The key findings of clinical studies outlined here have contributed to our understanding of the safety and efficacy profile of leadless pacemakers. These studies have demonstrated the potential to mitigate many of the complications associated with conventional pacing systems, making leadless pacemakers a compelling option for patients requiring cardiac pacing therapy.

 

Retrieval of Chronically Implanted Dual Chamber Leadless Pacemakers in an Ovine Model (2023)

Circulation: Arrhythmia and Electrophysiology, Sept 2023

This study explores the potential of leadless pacemakers (LPs) as an alternative to traditional transvenous pacemakers, focusing on the first dual chamber LP system designed for catheter-based retrieval. In a preclinical study involving nine ovine subjects, both atrial and ventricular LPs were implanted and successfully retrieved after approximately two years using a dedicated retrieval catheter. The retrieval process, involving snaring, docking, and unscrewing from the myocardium, demonstrated a 100% success rate without complications. Post-retrieval examinations revealed minimal tissue disruption, intact fibrous tissue, and no significant device-related issues. The study suggests the safe and effective long-term retrieval of implanted dual chamber LPs for upgrades or replacements, paving the way for future clinical studies on LP retrieval.

Primary Results of AVEIR™ DR i2i™ IDE Study on the World’s First Dual Chamber Leadless Pacemaker (2023)

The New England Journal of Medicine, May 2023

In a study evaluating this dual chamber leadless pacemaker system, researchers found that it successfully met the primary safety endpoint and performed well in terms of atrial pacing and atrioventricular (AV) synchrony at three months after implantation. The system, consisting of two devices—one implanted in the right atrium and the other in the right ventricle, demonstrated a high 98.3% success rate in implantation procedures and exceeded performance goals in safety and functionality. Furthermore, the study achieved its second primary performance end point with a 97.3% success rate, as defined by patients meeting at least 70% atrioventricular synchrony at 3 months while sitting. The study included 300 patients with various pacing indications, and the results suggest that this dual chamber leadless pacemaker system could expand treatment options for a broader range of indications compared to single chamber leadless pacemakers.

Primary Results on Safety and Efficacy From the LEADLESS II–Phase 2 Worldwide Clinical Trial (2022)

JACC: Clinical Electrophysiology, Jan 2022

This international phase 2 clinical trial approved by the Food and Drug Administration evaluated the safety and efficacy of a redesigned leadless pacemaker (LP), the AVEIR™ VR LP. The study enrolled 200 patients with standard VVI(R) pacing indications, predominantly atrial fibrillation with AV block (52.5%.) The primary safety end point was freedom from complications and the primary efficacy end point was 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 6 weeks of follow-up. Both primary end point results exceeded the performance goals with a 98% implant success rate. Of the successful implants, 83.2% did not require repositioning. These results support the use of AVEIR VR LP for right ventricular pacing as an alternative to transvenous pacemakers.

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