Abbott Highlights New AVEIR™ Data, Initiates Trial for the Company's Conduction System Pacing Technology
The Californer/10311994

* Late ~ San Diego, CA - Abbott, a leading medical technology company, has announced successful results from their first-in-human study of the AVEIR Conduction System Pacing (CSP) leadless pacemaker. The groundbreaking study demonstrated the safety and performance of this innovative technology, which specifically targets the left bundle branch area of the heart to restore its natural electrical rhythm.

The results were presented at the 46th annual meeting of the Heart Rhythm Society in San Diego and simultaneously published in the Heart Rhythm Journal. The study showed that all participants who received the AVEIR CSP leadless pacemaker had successful implantation deep into the wall separating the left and right chambers of the heart, with many achieving left bundle branch area pacing (LBBAP). Additionally, all participants received an AVEIR ventricular (VR) leadless pacemaker at the end of the procedure.

Dr. Vivek Y. Reddy, director of cardiac arrhythmia services at Mount Sinai Hospital in New York and principal investigator of the study, expressed excitement about these results. "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," he said. "This offers a novel approach to pacing therapy and may provide more treatment options for patients."

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Abbott is also making strides in their development of two unique approaches to conduction system pacing. In addition to completing their AVEIR CSP acute clinical feasibility study, they have begun enrolling patients in their ASCEND CSP pivotal clinical trial. This trial will evaluate Abbott's investigational CSP Implantable Cardioverter-Defibrillator (ICD) lead three months post-implant and aims to enroll up to 414 people at 70 sites worldwide.

The UltiPace Pacing Lead by Abbott is already FDA-approved for left bundle branch area placement and has recently been granted Breakthrough Device Designations for both the AVEIR CSP leadless pacemaker system and the CSP ICD lead for LBBAP. This designation expedites the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.

Randel Woodgrift, senior vice president of Abbott's cardiac rhythm management business, emphasized the potential impact of these advancements in conduction system pacing. "Our ongoing innovation in this area has the potential to drive meaningful advancements and offer new treatment options for people with slow or irregular heart rhythms," he said. "These two clinical studies highlight the critical importance of conduction system pacing in the left bundle branch area and demonstrate our commitment to improving outcomes for patients who require pacemaker and ICD therapies."

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