AVEIR^™ Leadless Pacemakers

Atrial Helix-Fixation Leadless Pacemaker: Real-World Single-Chamber Implant Experience (2025)

This multi-center real-world study assessed the AVEIR™ AR atrial leadless pacemaker in 75 patients with isolated sinus node dysfunction across 3 U.S. centers. Implant success was 100%. Average procedure time was 36 ± 33 min and fluoroscopy 7 ± 8 min; pre-fixation mapping prevented repositioning in 95% of cases. No acute or 30-day complications occurred, demonstrating a safe, efficient procedure with excellent electrical performance.

Commercial Implant Experience of a Helix-Fixation Dual-Chamber Leadless Pacemaker (2025)

In this commercial experience of the AVEIR™ DR dual-chamber leadless pacemaker, 175 patients across 8 centers underwent implantation with 99% complication-free outcomes at 30 days. Pre-fixation mapping eliminated repositioning in 95% of atrial and ventricular implants. The mean procedure time was 64 ± 33 minutes with fluoroscopy time of 13 ± 8 minutes. At discharge, electrical performance showed improved capture thresholds and sensed amplitudes. These findings confirm safe, efficient implantation and excellent early performance for the dual-chamber leadless pacing system in real-world practice.

One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker (2025)

In this AVEIR™ DR i2i Study with 300 patients, both 12-month safety and performance endpoints were achieved. The complication-free rate was 88.6% (P<0.001), surpassing the 76.5% performance goal, and 92.8% met the performance endpoint for atrial capture threshold (P<0.001). These results confirm that the dual-chamber leadless pacemaker maintained strong safety and electrical performance through one year, consistent with previously reported 3-month outcomes.

Dual-Chamber Leadless Pacemaker Implant Procedure Outcomes: Insights from the AVEIR DR i2i Study (2025)

In this AVEIR™ DR i2i study, AVEIR DR system was successfully implanted in 446 patients by 126 physicians. Mean procedure times were 90 ± 37 min (sheath insertion–removal), 74 ± 32 min (dual-chamber procedure), and 20 ± 13 min (fluoroscopy). With increased implant experience (≥9 procedures), procedural times reduced by 19–36% (P<.05), and freedom from complications improved from 89% to 98%. The findings demonstrate a high implant success rate and a clear learning curve, leading to greater procedural efficiency and safety over time.

Early Real‑World Implant Experience with a Helix‑Fixation Ventricular Leadless Pacemaker (2024)

In this multicenter real-world study of 167 patients, implantation of the helix-fixation AVEIR™ VR leadless pacemaker was successful in 98.8% of cases across 4 centers. Pre-fixation mapping eliminated the need for repositioning in 95.7% of implants, with median procedure and fluoroscopy times of 25.5 and 5.7 minutes, respectively. 98.2% of patients were free from acute adverse events. These results demonstrate a safe, efficient implant procedure with excellent electrical performance and low complication rates for the helix-fixation leadless system.

Atrioventricular Synchrony Delivered by a Dual-Chamber Leadless Pacemaker System (2024)

In this multicenter trial of 464 patients, the AVEIR™ DR dual chamber leadless pacemaker demonstrated exceptional performance in maintaining atrioventricular (AV) synchrony. 98% AV synchrony was achieved across all postures and activities at 3 months post-implant, surpassing both atrial-to-ventricular and ventricular-to-atrial i2i communication success rates (94%). The findings confirm robust, beat-to-beat AV synchrony and reliable wireless communication in real-world physiologic conditions

A Dual-Chamber Leadless Pacemaker (2023)

In this prospective, multicenter study of 300 patients implanted with AVEIR DR achieved a 98.3% implant success rate with reliable implant-to-implant communication. The primary safety endpoint—freedom from device- or procedure-related serious adverse events at 90 days—was met in 90.3% of patients, exceeding the prespecified goal (P<0.001). Overall, the system demonstrated high safety, reliable performance, and consistent AV synchrony, expanding leadless pacing to a broader patient population.