Setting the Pace with
AVEIR™ Leadless Pacemakers
Single and Dual Chamber Leadless Pacemakers (LP), only from Abbott
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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 profiles of leadless pacemakers. These studies have demonstrated potential to mitigate many of the complications associated with conventional pacing systems, making leadless pacemakers a compelling option for patients requiring cardiac pacing therapy.
In this study, early real-world implantation of the AVEIR AR2 atrial leadless pacemaker in 70 patients demonstrated 100% procedural success, no device-related complications, and improved electrical performance at follow-up. The procedure was efficient, with an average duration of ~12.5 minutes. Projected battery longevity reached ~12.9 years in AAI(R) and AAI(R)+VVI modes, representing a substantial improvement over prior device.
This real-world analysis compared AVEIR DR LP System with dual chamber transvenous pacemakers in de novo patients. At 6 months, AVEIR DR LP System significantly reduced overall complications (4.1% vs 6.9%; HR 0.59), device-related complications (2.8% vs 5.9%; HR 0.48), and reinterventions (2.1% vs 4.3%; HR 0.49), with no difference in mortality or heart failure hospitalizations.
This real-world analysis compared AVEIR AR Atrial LP with dual chamber and right-atrial transvenous pacemakers in sinus node dysfunction patients. Compared with dual chamber transvenous pacemakers, AVEIR AR Atrial LP demonstrated lower 30-day complications (6.7% vs 9.4%; OR 0.7) and significantly lower 1-year overall complications (3.6% vs 8.5%; HR 0.4), with similar mortality. AVEIR AR Atrial LP also reduced device-related complications and device reinterventions versus dual chamber transvenous systems.
This article presents a real-world comparative analysis evaluating the safety of AVEIR VR Ventricular LP vs single chamber transvenous ventricular pacemakers following FDA approval. Compared with transvenous VVI systems, AVEIR VR Ventricular LP demonstrated fewer acute device-related complications (1.4% vs 2.8%, p=0.002), similar overall 30-day complications (6.5% vs 6.8%) and cardiac effusion/perforation rates (0.4% vs 0.3%), and comparable 30-day mortality. At 12 months, AVEIR VR Ventricular LP was associated with a 30% lower overall complication rate (4.1% vs 5.7%, p=0.02), 47% fewer device-related complications (2.8% vs 5.2%, p=0.0002), 61% fewer reinterventions (1.2% vs 3.2%, p<0.0001), and lower all-cause mortality (17.0% vs 18.2%, p=0.02) compared with transvenous ventricular pacing.
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Across multiple HRS 2025 presentations, clinicians emphasized the growing roles of the AVEIR™ AR Atrial Leadless Pacemaker and the AVEIR DR Leadless Pacemaker System in providing personalized, physiological pacing for patients with sinus node dysfunction (SND). Real-world studies and case experiences demonstrated high implant success rates, excellent electrical performance, low complication rates, and the flexibility to upgrade from atrial-only to dual chamber pacing as patient needs evolve. Presenters highlighted strategies for tailoring leadless pacing systems that reduce risks of transvenous leads while enabling adaptable, long-term management.
Atrial Helix-Fixation Leadless Pacemaker: Real-World Single Chamber Implant Experience (2025)
This multi-center, real-world study assessed the AVEIR™ AR Atrial LP in 75 patients with isolated SND 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 LP System, 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.
In this AVEIR™ DR i2i study, AVEIR DR LP 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.
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