Abbott Highlights New AVEIR™ Data, Initiates Trial for the Company's Conduction System Pacing Technology
Rhea-AI Summary
Abbott (NYSE: ABT) announced breakthrough results from its AVEIR™ Conduction System Pacing (CSP) acute clinical feasibility study, the world's first assessment of a leadless pacemaker delivering conduction pacing to the heart's left bundle branch area. The study demonstrated successful implantation of the AVEIR CSP leadless pacemaker technology.
Additionally, Abbott has initiated the ASCEND CSP pivotal clinical trial to evaluate their investigational CSP Implantable Cardioverter-Defibrillator lead, which will enroll up to 414 people across 70 global sites. The company received FDA Breakthrough Device Designations for both the AVEIR CSP leadless pacemaker system and the CSP ICD lead for left bundle branch area pacing (LBBAP).
Abbott's UltiPace™ Pacing Lead became the first FDA-approved stylet-driven lead indicated for left bundle branch area placement, marking significant progress in their cardiac rhythm management portfolio.
Positive
- Successful completion of first-in-human study for AVEIR CSP leadless pacemaker
- FDA Breakthrough Device Designations received for two cardiac technologies
- First FDA approval obtained for UltiPace Pacing Lead
- Launch of large-scale ASCEND CSP pivotal trial across 70 global sites
Negative
- None.
News Market Reaction – ABT
In the trading session that priced this news, ABT gained 0.53%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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- 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
- Enrollment has also begun in the ASCEND CSP pivotal clinical trial to evaluate Abbott's investigational CSP Implantable Cardioverter-Defibrillator (ICD) lead
- Conduction System Pacing is an evolving technique specifically designed to deliver pacing to the left bundle branch area of the heart to restore its natural electrical rhythm
The results were presented as a late-breaking clinical trial at the Heart Rhythm Society's (HRS) 46th annual meeting in
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.
"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,
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.
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
Abbott's UltiPace™ Pacing Lead is the first FDA-approved stylet-driven lead indicated for left bundle branch area placement. Recently, the
"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."
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.
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SOURCE Abbott