Abbott's AVEIR Feasibility Study Shows Promising Safety And Performance For Leadless Pacemaker Tech

Abbott Laboratories

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(RTTNews) - Abbott (ABT) announced data from the AVEIR Conduction System Pacing acute clinical feasibility study, which demonstrated the safety and performance of the investigational AVEIR Conduction System Pacing leadless pacemaker technology.

The AVEIR Conduction System Pacing acute clinical feasibility study is the world's first assessment of a leadless pacemaker delivering conduction pacing to the heart's left bundle branch (LBB) area. Conduction System Pacing (CSP) is a novel pacing approach that targets the LBB area by enabling pacing that mimics the heart's natural electrical rhythm.

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

Abbott said that, to maximize potential benefits to patients, the company is developing two unique approaches to conduction system pacing, focusing on targeting the LBB area with both traditional pacing and leadless technology.

In addition, Abbott said it recently started enrolling the first patients in the ASCEND CSP pivotal clinical trial. The 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 United States, Canada, Europe and the Asia-Pacific region.

Abbott's UltiPace Pacing Lead is the first FDA-approved stylet-driven lead indicated for left bundle branch area placement. Recently, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designations to both Abbott's AVEIR CSP leadless pacemaker system and the CSP ICD lead for LBBAP.