Abbott has announced significant developments in its AVEIR Conduction System Pacing (CSP) technology, which were presented during the Heart Rhythm Society's 46th annual meeting in San Diego and published in the Heart Rhythm Journal. The highlight was the successful results from Abbott's AVEIR CSP acute clinical feasibility study, which is the first in-human study to assess a leadless pacemaker delivering conduction pacing to the heart's left bundle branch area.
"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., principal investigator of the study.
Additionally, Abbott has begun enrollment in the ASCEND CSP pivotal clinical trial. This trial will evaluate the safety and effectiveness of the CSP Implantable Cardioverter-Defibrillator (ICD) lead over a three-month period and will include up to 414 participants globally. The aim is to reduce complications and improve outcomes for patients needing ICD therapy.
According to Randel Woodgrift, Senior Vice President of Abbott's cardiac rhythm management business, "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."
The U.S. FDA has granted Breakthrough Device Designations to both Abbott's AVEIR CSP leadless pacemaker system and the CSP ICD lead, aiming to expedite the review of these innovative technologies.
Abbott continues to develop its cardiac rhythm management portfolio, strengthening its commitment to conduction system pacing with both traditional and leadless technologies.
Abbott, with a workforce of 114,000, operates in over 160 countries and offers technologies in diagnostics, medical devices, nutritionals, and branded generic medicines.