- Abbott's AVEIR™ DR i2i™ IDE study is the industry's first
prospective study on the safety and performance of the world's
first dual-chamber leadless pacemaker
- The study successfully met all three of its primary safety and
performance endpoints
- Abbott's investigational AVEIR DR leadless pacemakers have been
submitted for evaluation by the U.S. FDA
NEW
ORLEANS, May 20, 2023 /PRNewswire/ -- Abbott (NYSE:
ABT) today announced late-breaking results from the AVEIR™
dual-chamber (DR) i2i™ Investigational Device Exemption (IDE)
study, a large-scale study to assess the world's first dual-chamber
leadless pacemaker, showing that the leadless pacemaker met its
three prespecified primary endpoints for safety and performance.
The data further suggests that AVEIR DR could offer new benefits
for people with slower-than-normal heart rhythms.
The results are being presented during a late-breaking clinical
trial session at the Heart Rhythm Society's (HRS) 44th
annual meeting in New Orleans,
(May 19-21, 2023), and simultaneously
published in The New England Journal of Medicine. The data
has been provided to the U.S. Food and Drug Administration (FDA) as
part of Abbott's submission for approval of the AVEIR DR
device.
People who experience a slower-than-normal heart rate have
traditionally received a pacemaker, which is a small
battery-powered device implanted underneath the skin in the chest.
The device delivers electrical impulses directly to the heart
muscle via thin insulated wires, known as cardiac leads, to restore
a normal heart rhythm. Unlike traditional pacemakers, leadless
pacemakers are implanted directly into the heart through a
minimally invasive, catheter-based procedure. This eliminates the
need for cardiac leads and a pulse generator under the skin.
While many people require pacing and sensing in both the right
atrium and the right ventricle, currently available leadless
pacing options have been limited to single-chamber ventricular
devices because seamless, wireless synchronization of two leadless
pacemakers has been a significant technological challenge.
"The vast majority of people needing a pacemaker require a
dual-chamber pacemaker and would greatly benefit from a leadless
device – but we've simply never had that option due to engineering
challenges," said Reinoud E. Knops, M.D., Ph.D., professor of
medicine, Amsterdam University Medical Center, Netherlands, and co-principal investigator of
the AVEIR DR i2i IDE study. "Data from the AVEIR DR i2i study show
that Abbott has designed a groundbreaking technology for seamless
communication between two leadless pacemakers, and that AVEIR DR
can deliver appropriate therapy safely, opening up a future
treatment option for more people with abnormal heart
rhythms."
Abbott designed the AVEIR DR leadless pacemaker – the DR
denoting dual-chamber rate response – with a first-of-its-kind i2i
(implant-to-implant) technology, with the goal of providing
beat-to-beat communication and synchrony between two leadless
pacemakers, a necessary foundation of dual-chamber leadless pacing
therapy. Unlike other leadless pacemakers, this system allows the
two devices to communicate with each other — sensing for delayed or
missed heartbeat and then pacing the appropriate chamber of the
heart.
In addition, Abbott's AVEIR leadless devices utilize specially
designed attachment mechanisms that allow retrieval of the
pacemakers when changes in therapy are needed. In the AVEIR DR i2i
IDE study, physicians successfully implanted leadless pacemakers in
the right atrium along with a leadless device implanted in the
right ventricle for the first time.
Late-Breaking Data from the AVEIR DR i2i IDE
Study
Under the AVEIR DR i2i IDE study, primary safety and
efficacy endpoints were analyzed in the first 300 people enrolled
across 55 centers in the United
States, Canada and
Europe. The design goals of AVEIR DR1 include
technologies to regulate the heart rate synchronously and
continuously between both chambers that enable true dual-chamber
leadless pacing.
Results of the AVEIR DR i2i IDE study through three-months
post-implant showed:
- Physicians demonstrated a 98.3% implant success rate.
- Safety endpoint evaluating freedom from device or procedure
complications was achieved.
- More than 97% of people had successful atrio-ventricular (AV)
synchrony, so that the upper and lower chambers were beating
normally, despite different types of underlying slow heart
rhythms.
- The average AV synchrony was more than 95% in each of seven
different posture and walking speeds, demonstrating the system will
function appropriately during everyday life activities.
"For the first time, the AVEIR DR i2i study has shown that a
dual-chamber leadless pacing device is not only possible but can
meet the rigors of everyday needs of pacing therapy," said
Randel Woodgrift, senior vice
president of Abbott's cardiac rhythm management business. "The
results of the AVEIR DR study are a strong indicator that the AVEIR
dual-chamber pacemakers can offer new options so that physicians
can treat a broader group of people that need pacemaker therapies.
"
About the AVEIR DR i2i IDE Study
The objective of the
AVEIR DR i2i IDE study is to demonstrate that the AVEIR DR leadless
pacemaker is safe and effective for people who experience a
slower-than-normal or irregular heart rate and may receive a
dual-chamber pacemaker to help restore a more normal heart rate.
The AVEIR DR i2i IDE study is a prospective, multi-center,
international, single-arm, pivotal investigational study.
Behind the AVEIR Technology
Smaller than a AAA
battery, the AVEIR leadless pacemaker is implanted via a minimally
invasive procedure, the device attaches to the heart's interior
wall with a screw-in mechanism, known as a helix, that allows for
the leadless pacemaker to be retrieved should therapy needs evolve
or if the device needs to be replaced in the future. The
ventricular and atrial leadless devices are also designed to
provide real-time mapping capability so physicians can assess
proper placement of the device before it is
implanted. The novel i2i communication technology
provides synchronized or coordinated cardiac pacing between two
leadless pacemakers based on the person's beat-to-beat clinical
needs. The AVEIR system is modular, such that a single device can
be implanted in a heart chamber initially, and the second pacemaker
added to the other heart chamber in the future should the clinical
need arise. AVEIR leadless pacemakers are designed for retrieval,
should therapy needs change in the future. The device design
specifications are subject to change pending regulatory review.
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 115,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at http://www.facebook.com/Abbott and on
Twitter @AbbottNews.
1 The design goals of AVEIR DR are subject to change
pending FDA review.
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SOURCE Abbott