Abbott Announces First-in-World Leadless Pacing Procedures in the Left Bundle Branch Area of the Heart

Rhea-AI Summary

Abbott (NYSE: ABT) has achieved a significant milestone by completing the world's first leadless left bundle branch area pacing (LBBAP) procedures using their investigational AVEIR™ Conduction System Pacing (CSP) leadless pacemaker system. The procedures were conducted as part of a feasibility study evaluating the system's acute safety and performance.

The innovative device, which has received FDA Breakthrough Device Designation, is designed to deliver pacing to the left bundle branch area, activating the heart's natural conduction system. This approach combines the benefits of both conduction system pacing and leadless pacing technologies, potentially offering improved physiological response compared to traditional pacing options.

The procedures were performed by Prof. Petr Neužil at Na Homolce Hospital in Prague and Dr. Vivek Y. Reddy from Mount Sinai Hospital in fall 2024.

Positive

• Received FDA Breakthrough Device Designation, expediting the review process
• First-in-world achievement in leadless left bundle branch area pacing
• Technology eliminates need for cardiac leads and pulse generator under skin
• Potential to reduce complications associated with traditional pacemakers

Negative

• System still in investigational phase with only feasibility study results
• Long-term safety and efficacy data not yet available

Insights

Medical Research Analyst

The first-in-human trials of Abbott's AVEIR™ CSP leadless pacemaker represent a significant breakthrough in cardiac rhythm management. The device's innovative approach to left bundle branch area pacing (LBBAP) combines two advanced technologies - leadless pacing and conduction system pacing - into a single solution. The FDA Breakthrough Device Designation signals the technology's potential to address unmet medical needs. Traditional pacemakers require leads and subcutaneous pulse generators, which can lead to complications. This new system eliminates these risks while potentially improving physiological heart response through more natural electrical conduction patterns. The successful completion of first-in-human procedures marks a important milestone in the device's development pathway.

Financial Analyst

This development strengthens Abbott's position in the $4.5 billion global cardiac rhythm management market. The innovative AVEIR™ CSP system could create a new premium segment in the pacemaker market, potentially driving higher margins and market share gains. Abbott's strategic focus on breakthrough cardiac technologies demonstrates its commitment to maintaining leadership in high-growth medical device segments. The FDA Breakthrough Device Designation should accelerate the pathway to commercialization, potentially leading to faster market penetration and revenue generation. This innovation could help Abbott capture a larger share of the growing elderly patient population requiring cardiac rhythm management solutions.

• Abbott's investigational AVEIR™ Conduction System Pacing (CSP) leadless pacemaker system is specifically designed to deliver pacing to the left bundle branch area, activating the heart's natural conduction system
• The device has received U.S. Food and Drug Administration Breakthrough Device Designation, which expedites the review of innovative technologies
• By creating a new pacing approach for the left bundle branch area of the heart, Abbott continues to pursue technologies to revolutionize care for people with slow or irregular heart rhythms

ABBOTT PARK, Ill., Dec. 17, 2024 ­­­/PRNewswire/ -- Abbott (NYSE: ABT) today announced the successful completion of the world's first in-human leadless left bundle branch area pacing (LBBAP) procedures using the company's investigational AVEIR™ Conduction System Pacing (CSP) leadless pacemaker system, as part of a feasibility study. These procedures mark the first time a leadless pacemaker has been implanted into the left bundle branch area, a key part of the heart's electrical conduction system, designed to mimic the heart's natural beat, offering people with slower-than-normal heart rhythms a new potential treatment option.

The landmark procedures were part of the prospective Leadless CSP feasibility study, which evaluates the acute safety and performance of the investigational AVEIR CSP leadless pacemaker system. The procedures were completed in the fall of 2024 by Professor Petr Neužil, M.D., Ph.D., head of the department of cardiology at Na Homolce Hospital in Prague, Czech Republic, and the site's principal investigator, and Vivek Y. Reddy, M.D., director of cardiac arrhythmia services at Mount Sinai Hospital, New York, and the study's principal investigator.

"While both conduction system pacing and leadless pacing provide distinct benefits to many patients, they have been separate options – until now," said Devi Nair, M.D., director of cardiac electrophysiology at St. Bernards Medical Center, Jonesboro, Arkansas, and a key contributor to the study. "For the first time, the study of the AVEIR CSP leadless pacemaker system evaluates a pioneering approach that directly targets the left bundle branch area, combining the advantages of conduction system and leadless pacing technologies."

CSP is an evolving technique in which a traditional pacemaker wire is implanted deep into the wall separating the left and right chambers of the heart. This approach activates the left bundle branch area enabling physiological pacing which mimics the heart's natural electrical current. As a result, physicians believe this pacing approach could improve the physiological response from the heart compared with other pacing options.

The seamless integration of CSP procedures with leadless pacemaker technology has the potential to deliver unique benefits over traditional pacemakers. Leadless pacing systems eliminate the need for cardiac leads and a pulse generator under the skin and avoid long-term risks of lead- and pocket-related complications. As a result, leadless pacemakers like the AVEIR family of products are a potential solution for some of the complications often associated with traditional pacemakers.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to explore the use of Abbott's AVEIR CSP leadless pacemaker system 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.

"Bringing our proven leadless pacemaker technology to the left bundle branch area has great potential to be another transformative moment in cardiac care," said Randel Woodgrift, senior vice president of Abbott's cardiac rhythm management business. "By continuously innovating our approach to pacing, Abbott is revolutionizing care for millions of people living with slow or irregular heart rhythms."

Completing the research team were Rahul Doshi, M.D., chief cardiac arrhythmia group at HonorHealth, Scottsdale, Arizona; and Shephal Doshi, M.D., executive director at Heart and Vascular Institute, Providence Saint John's Health Center, Santa Monica, California -- key contributors in the feasibility study and completion of the procedures.

About the AVEIR Leadless Pacemaker System
Abbott's AVEIR dual chamber (DR) leadless pacemaker system received FDA approval in June of 2023. Through its novel i2i™ (implant-to-implant) technology, the AVEIR DR leadless pacemaker system provides synchronized pacing by utilizing high-frequency electrical impulses to relay messages between co-implanted leadless pacemakers via the naturally conductive characteristics of the body's blood and tissue. The AVEIR CSP leadless pacemaker system is in development and not commercially available. 

To find more information on AVEIR leadless pacemakers, visit: https://bit.ly/3zcmkRJ.

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

FAQ

What is the breakthrough technology Abbott (ABT) announced for heart pacing?

Abbott announced the first-in-world leadless left bundle branch area pacing procedures using their investigational AVEIR™ Conduction System Pacing leadless pacemaker system, designed to activate the heart's natural conduction system.

How does Abbott's AVEIR CSP leadless pacemaker differ from traditional pacemakers?

The AVEIR CSP system eliminates the need for cardiac leads and pulse generator under the skin, potentially reducing complications associated with traditional pacemakers while targeting the left bundle branch area for more natural heart rhythm activation.

What is the significance of FDA Breakthrough Device Designation for Abbott's AVEIR pacemaker?

The FDA Breakthrough Device Designation expedites the review process for Abbott's AVEIR CSP system, recognizing it as an innovative technology that could improve the lives of people with life-threatening or irreversibly debilitating conditions.

When were the first AVEIR CSP leadless pacemaker procedures performed?

The first procedures were completed in fall 2024 at Na Homolce Hospital in Prague, Czech Republic, as part of the Leadless CSP feasibility study.

What are the potential benefits of Abbott's new leadless pacing technology?

The technology aims to improve physiological response from the heart compared to other pacing options, while reducing complications associated with traditional pacemakers by eliminating leads and pocket-related issues.