Abbott's Groundbreaking AVEIR Leadless Pacemaker Shows Promise in First-in-Human Conduction System Pacing Study
Key Insights
Abbott's AVEIR (search) Conduction System Pacing (search) leadless pacemaker demonstrated successful implantation in the left bundle branch (search) area of the heart in a first-of-its-kind feasibility study presented at HRS 2025.
The company has initiated the ASCEND CSP pivotal trial to evaluate its investigational Conduction System Pacing (search) Implantable Cardioverter-Defibrillator lead, which will enroll up to 414 patients across 70 global sites.
Both the AVEIR (search) CSP leadless pacemaker and CSP ICD lead have received FDA Breakthrough Device Designation, potentially accelerating development of physiologic pacing options for patients with cardiac rhythm disorders.
Abbott announced promising results from the world's first assessment of a leadless pacemaker designed to deliver conduction pacing to the heart's left bundle branch (search) area. The late-breaking data from the AVEIR (search) Conduction System Pacing (search) (CSP) acute clinical feasibility study demonstrated both safety and performance of the investigational technology.
The results were presented at the Heart Rhythm Society's 46th annual meeting in San Diego on April 27, 2025, and simultaneously published in the Heart Rhythm Journal.
The study successfully demonstrated the implantation of the AVEIR (search) CSP leadless pacemaker deep into the wall separating the left and right chambers of the heart, with many achieving left bundle branch (search) area pacing (LBBAP). This novel approach targets the left bundle branch area to enable pacing that mimics the heart's natural electrical rhythm.
"For the first time, we have successfully demonstrated the feasibility of a leadless pacing system to facilitate conduction system pacing (search) in the left bundle branch (search) area of the heart, offering a novel approach to pacing therapy," said Vivek Y. Reddy, M.D., director of cardiac arrhythmia services at Mount Sinai Hospital, New York, and the study's principal investigator.
Dr. Reddy added, "Leadless pacing has already demonstrated significant benefits to patients. This new groundbreaking approach may enable a more physiologic way of stimulating the heart with Abbott's AVEIR (search) CSP leadless pacemaker system, giving patients more treatment options."
Dual Approach to Conduction System Pacing
Abbott is pursuing two distinct approaches to conduction system pacing (search), both focusing on the left bundle branch (search) area. The company is developing both traditional lead-based and leadless pacing technologies to maximize potential benefits for patients with cardiac rhythm disorders.
In addition to the AVEIR (search) CSP study, Abbott has begun enrolling patients in the ASCEND CSP pivotal clinical trial. This study will evaluate the safety and effectiveness of the investigational CSP Implantable Cardioverter-Defibrillator (ICD) lead three months post-implant. The trial will include up to 414 participants across 70 sites worldwide, spanning the United States, Canada, Europe, and the Asia-Pacific region.
The uniquely designed CSP ICD lead aims to reduce complications, enhance pacing precision, and improve long-term outcomes for patients requiring defibrillator therapy.
Regulatory Recognition and Existing Portfolio
Abbott's commitment to conduction system pacing (search) innovation has already yielded significant regulatory milestones. The company's UltiPace (search) Pacing Lead became the first FDA-approved stylet-driven lead indicated specifically for left bundle branch (search) area placement.
More recently, the U.S. Food and Drug Administration granted Breakthrough Device Designations to both Abbott's AVEIR (search) CSP leadless pacemaker system and the CSP ICD lead for left bundle branch (search) area pacing. This designation expedites the review process for innovative technologies that address life-threatening or irreversibly debilitating conditions.
"Our ongoing innovation in conduction system pacing (search) has the potential to drive meaningful advancements, offering new potential treatment options for people with slow or irregular heart rhythms," said Randel Woodgrift, senior vice president of Abbott's cardiac rhythm management business.
Woodgrift emphasized the significance of the clinical studies: "These two clinical studies underscore the critical importance of conduction system pacing (search) in the left bundle branch (search) area both with our breakthrough leadless technology and uniquely designed lead, enabling physicians to better treat a broader range of patients who require pacemaker and ICD therapies."
Clinical Significance of Conduction System Pacing
Conduction system pacing (search) represents an evolution in cardiac rhythm management. Traditional pacing methods can sometimes create electrical patterns that differ from the heart's natural conduction, potentially leading to long-term complications. By targeting the left bundle branch (search) area, conduction system pacing aims to preserve or restore the heart's intrinsic electrical activation sequence.
This approach may be particularly beneficial for patients with bradycardia (search) (slow heart rate) who require pacing support, as well as those with heart failure (search) who need cardiac resynchronization therapy. The physiologic pacing pattern could potentially reduce the risk of pacing-induced cardiomyopathy (search) and improve overall cardiac function.
The development of leadless options for conduction system pacing (search) further expands the potential patient population who might benefit from this approach, as it eliminates lead-related complications such as infection, venous occlusion, and lead fracture.
As Abbott continues to advance both the AVEIR (search) CSP leadless pacemaker and the CSP ICD lead through clinical trials, the company is positioning itself at the forefront of physiologic pacing innovation, potentially transforming treatment options for patients with cardiac rhythm disorders.