Data Supports Abbott’s Aveir Conducting System Pacing

Abbott released late-breaking data from its Aveir conduction system pacing (CSP) acute clinical feasibility study, which evaluated safety and performance of the investigational Aveir CSP leadless pacemaker.

According to the company, the study is the world’s first assessment of a leadless pacemaker delivering conduction pacing to the heart’s left bundle branch (LBB) area. CSP targets the LBB area by allowing pacing that mimics the heart’s natural electrical rhythm.

The acute clinical feasibility study showed successful implantation of Aveir CSP deep into the wall separating the heart’s left and right chambers, many achieving left bundle branch area pacing (LBBAP). All study participants received the Aveir ventricular (VR) leadless pacemaker at the end of the procedure.

In addition to completing this study, Abbott recently began enrolling intial patients in the ASCEND CSP pivotal clinical trial. This trial will evaluate the safety and effectiveness of the investigational CSP implantable cardioverter-defibrillator (ICD) lead three months post-implant and will enroll up to 414 people at up to 70 sites worldwide, including in the U.S., Canada, Europe ,and the Asia-Pacific region. This lead aims to reduce complications, enhance pacing precision, and improve long-term outcomes for patients requiring ICD therapy.

The company’s UltiPace pacing lead is the first FDA-approved, stylet-driven lead for left bundle branch area placement. Abbott recently earned breakthrough status for both the Aveir CSP and the CSP ICD lead for LBBAP.

“For the first time, we have successfully demonstrated the feasibility of a leadless pacing system to facilitate conduction system pacing in the left bundle branch area of the heart, offering a novel approach to pacing therapy,” said Vivek Reddy, MD, director of cardiac arrythmia services at Mount Sinai Hospital, New York, and the study’s principal investigator. “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 CSP leadless pacemaker system, giving patients more treatment options.”

“Our ongoing innovation in conduction system pacing has the potential to drive meaningful advancements, offering new potential treatment options for people with slow or irregular heart rhythms,” said Randel Woodgrift, senior VP of Abbott’s cardiac rhythm management business. “These two clinical studies underscore the critical importance of conduction system pacing in the left bundle branch 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.”