Core Insights - Abbott announced late-breaking data from the AVEIR Conduction System Pacing (CSP) acute clinical feasibility study, demonstrating the safety and performance of its leadless pacemaker technology [1][4] - The study is the first to assess a leadless pacemaker delivering conduction pacing to the heart's left bundle branch area, offering a novel approach to pacing therapy [1][4] Clinical Study Results - The AVEIR CSP acute clinical feasibility study showed successful implantation of the leadless pacemaker deep into the wall separating the left and right chambers of the heart, with many participants achieving left bundle branch area pacing [3] - All study participants received the AVEIR ventricular leadless pacemaker at the end of the procedure [3] Future Developments - Abbott has begun enrolling patients in the ASCEND CSP pivotal clinical trial, which will evaluate the safety and effectiveness of the investigational CSP Implantable Cardioverter-Defibrillator (ICD) lead [6] - The trial aims to enroll up to 414 people at 70 sites worldwide, focusing on reducing complications and improving long-term outcomes for patients requiring ICD therapy [6] Regulatory Milestones - Abbott's UltiPace Pacing Lead is the first FDA-approved stylet-driven lead for left bundle branch area placement [7] - The FDA granted Breakthrough Device Designations to both the AVEIR CSP leadless pacemaker system and the CSP ICD lead for left bundle branch area pacing, expediting the review of these innovative technologies [7] Strategic Focus - Abbott is developing two unique approaches to conduction system pacing, targeting the left bundle branch area with both traditional and leadless technology [5] - The ongoing innovation in conduction system pacing is expected to drive advancements in treatment options for patients with slow or irregular heart rhythms [8]
Abbott Highlights New AVEIR™ Data, Initiates Trial for the Company's Conduction System Pacing Technology