- 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