- Abbott's investigational Aveir™ DR dual-chamber pacemaker is
designed to provide synchronous, beat-by-beat pacing of the right
atrium and right ventricle of the heart
- Proprietary implant-to-implant (i2i™) device technology is
used for communication between two implanted leadless pacemakers to
regulate the heart rate
- Aveir DR is also specifically designed to be retrieved if
therapy needs evolve
ABBOTT PARK, Ill.,
Feb. 7, 2022 /PRNewswire/
-- Abbott (NYSE: ABT) today announced the world's first
patient implants of a dual-chamber leadless pacemaker system as
part of its AVEIR DR i2i™ pivotal clinical study. The implant of
Abbott's investigational Aveir™ dual-chamber leadless pacemaker
represents a significant technological milestone for leadless
pacing technology and is the first to occur around the world within
the pivotal trial.
The study is being co-chaired by Daniel
J. Cantillon, M.D., clinical trial steering committee
co-chair and Associate Section Head and Research Director of
Cardiac Electrophysiology and Pacing, Cleveland Clinic. M.D., and
Reinoud Knops, M.D., Ph.D., clinical trial steering committee
co-chair and Department of Cardiology and Electrophysiology,
Amsterdam University Medical Center, The
Netherlands.
People who experience a slower-than-normal heart rate may
receive a pacemaker -- a small battery-powered device implanted in
the chest that delivers electrical impulses via thin insulated
wires, called cardiac leads, that cause the heart muscle chambers
to contract to help restore a normal heart rhythm. Unlike
traditional pacemakers, leadless pacemakers are implanted directly
into the heart through a minimally invasive catheter-based
procedure and eliminate the need for cardiac leads. While leadless
pacemakers work like traditional pacemakers to regulate heart rate,
they offer reduced lead-related complications and a less
restrictive recovery period due to the minimally invasive implant
procedure.i Yet historically, leadless pacing options
have been limited to single-chamber devices because synchronization
of two leadless pacemakers has been highly difficult to
achieve.
Abbott solved for this challenge by designing the company's
innovative "i2i technology" to provide beat-by-beat
communication between two leadless pacemakers, one positioned in
the right ventricle and one positioned in the right atrium. This
technology is designed to regulate the heart rate synchronously
between chambers and allow for true dual-chamber leadless
pacing.
The first implant was performed at Na Homolce Hospital in
Prague, Czech Republic, led by
site principal investigator Petr
Neuzil, M.D., Ph.D., Head of the Department of Cardiology,
and assisted by site co-investigator, Vivek
Y. Reddy, M.D.
"The first-in-human implant of a dual-chamber leadless pacemaker
is a major clinical milestone that will open up new possibilities
for patients requiring pacing support," said Dr. Daniel J. Cantillon. "Abbott has designed a
device capable of treating these patients, and we're excited to see
this technology advance patient care."
Abbott has focused significantly on driving leadless pacing
technology that can potentially improve care for more patients
battling abnormal heart rhythms. The latest milestone for the Aveir
DR leadless pacemaker follows recent data showing that Abbott's
investigational single-chamber leadless pacemaker – Aveir VR – met
the pre-specified primary endpoints in its pivotal trial.
"As leadless pacing technology has evolved, we've always viewed
dual chamber leadless technology as a therapy evolution that would
have a dramatic impact on more patients – but a technology that was
going to be very challenging to develop," Dr. Reinoud Knops.
"That we've reached this point in time where dual chamber pacing
without leads has become a reality is a monumental moment for
modern medicine."
Because nearly 80% of people who receive a pacemaker need a
dual-chamber option to pace both chambers on the right side of the
heart, Aveir DR has been designed to address a critical need for
these patients. Abbott also designed the Aveir DR leadless
pacemaker to be retrievable, so the system can be replaced or
retrieved as therapy needs evolve. The Aveir DR system is designed
to provide real-time mapping capability so physicians can assess
therapy delivery and reposition the device before implant during a
patient's procedure.
"The Aveir DR dual-chamber leadless pacemaker builds upon our
Aveir VR single-chamber leadless platform, and we believe that once
approved these systems have the potential to change the way doctors
approach the treatment of abnormal heart rhythms," said
Randel Woodgrift, senior vice
president of Abbott's cardiac rhythm management business. "The
involvement of world-class heart institutions in this study
reinforces that the innovations we are developing are exactly the
kind of advancements physicians around the world want for their
patients."
ABOUT THE AVEIR DR I2I STUDY
The Aveir DR i2i study is
a prospective, multicenter, international, single-arm, pivotal
investigational study designed to evaluate the clinical safety and
efficacy of the Aveir DR leadless pacemaker in patients who were
indicated for a DDD(R) – or dual-chamber bradycardia pacing –
pacemaker, which stimulates the appropriate chamber of the heart
when clinically necessary. The study plan is to enroll up to 550
patients from up to 80 sites in the U.S., Canada, Europe and Asia-Pacific, and all patients will be
followed for a minimum of 12 months post-implant.
The Aveir DR i2i leadless pacemaker is an investigational device
being clinically evaluated as part of a global pivotal study and is
not yet commercially available. The device design specifications
are subject to change.
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 113,000 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 www.facebook.com/Abbott and on
Twitter @AbbottNews.
i.
Sattar Y, Ullah W, Roomi S, Rauf H, Mukhtar M, Ahmad A, Ali Z,
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Hosp Intern Med Perspect. 2020 Aug
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