Late-breaking data from Abbott’s groundbreaking first-in-human study demonstrated successful implantation of the company’s AVEIR Conduction System Pacing (CSP) leadless pacemaker
Abbott announced late-breaking data from the AVEIR Conduction System Pacing (CSP) acute clinical feasibility study, which demonstrated the safety and performance of the investigational AVEIR CSP leadless pacemaker technology. The AVEIR CSP 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. CSP is a novel pacing approach that targets the LBB area by enabling pacing that mimics the heart’s natural electrical rhythm.
Health Technology Insights: Health Net, Partners Team Up to Improve Care in Sacramento
The results were presented as a late-breaking clinical trial at the Heart Rhythm Society’s (HRS) 46th annual meeting in San Diego and simultaneously published in the Heart Rhythm Journal.
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. All study participants received the AVEIR ventricular (VR) leadless pacemaker at the end of the procedure.
“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 Y. Reddy, M.D., 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.”
Conduction Pacing Momentum within Abbott‘s Cardiac Rhythm Management Portfolio
To maximize potential benefits to patients, Abbott is developing two unique approaches to conduction system pacing, focusing on targeting the LBB area with both traditional pacing and leadless technology.
Health Technology Insights: Paige and NHS Wales Launch AI PanCancer Pilot at Betsi Cadwaladr
In addition to completing the AVEIR CSP acute clinical feasibility study, Abbott recently started enrolling the first 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 United States, Canada, Europe and the Asia-Pacific region. This uniquely designed lead aims to reduce complications, enhance pacing precision, and improve long-term outcomes for patients requiring ICD therapy.
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. Breakthrough Device Designation expedites the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.
“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 vice president 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.”
Health Technology Insights: Socially Determined, Acentra Partner to Advance Population Health
To participate in our interviews, please write to our HealthTech Media Room at sudipto@intentamplify.com
Source – PR Newswire
