- Abbott's Aveir single chamber (VR) pacing system is the world's
only leadless pacemaker with a unique mapping capability to assess
correct positioning prior to placement
- Aveir VR has an increased projected battery life that can be up
to two times longer than other commercially available leadless
pacemakers when using the International Organization for
Standardization (ISO) standard settings
- Aveir VR is specifically designed to be retrieved when therapy
needs evolve or the device needs to be replaced
PARK, Ill., April 4,
2022 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced that the U.S. Food and Drug Administration (FDA) has
approved the Aveir™ single-chamber (VR) leadless pacemaker for the
treatment of patients in the U.S. with slow heart rhythms. This
marks significant advancement for patient care and brings new,
never-before-seen features to patients and their physicians.
The Aveir leadless pacemaker is implanted directly inside the
heart's right ventricle via a minimally invasive procedure to treat
slower-than-normal heart rates. Unlike traditional pacemakers,
leadless pacemakers do not require an incision in the chest to
implant the device or cardiac leads to deliver therapy.
The device has a unique mapping capability designed to allow
physicians to measure electrical signals within the heart and
determine the correct placement of the device before final
implantation. It has an increased projected battery life that can
be up to two times longer than other currently commercially
available leadless pacemakers when using International Organization
for Standardization (ISO) standard settings.1 In
addition, the device is the only leadless pacemaker designed to be
retrieved if therapy needs evolve.
"The Aveir leadless pacemaker offers an exciting option for the
treatment of people with cardiac arrhythmias. Leadless pacemakers
address known complications associated with traditional pacemakers.
In addition, the Aveir leadless pacemaker brings unique innovations
we've been seeking, such as the ability to ensure electrical
performance before we commit to placement," said Rahul Doshi, M.D., Director of
Electrophysiology, Honor Health. "Abbott's leadless pacemaker
addresses the need for a single-chamber device that accommodates
any therapy path for a patient through Aveir's retrieval capability
and extended battery longevity."
This approval is supported by data from the global LEADLESS II
phase 2 investigational device exemption (IDE) study evaluating
Aveir VR in patients with certain abnormal heart rhythms. The
results showed the device met its pre-specified primary endpoints.
The findings were presented at the annual Scientific Sessions of
the Asia Pacific Heart Rhythm Society (APHRS) in November 2021 and simultaneously published in the
Journal of the American College of Cardiology: Clinical
"The Aveir VR leadless pacemaker was designed to make the
implantation and retrieval processes as seamless as possible for
physicians and provide improvements over existing options," said
Randel Woodgrift, senior vice
president, Cardiac Rhythm Management, Abbott. "Our goal is to
continue to build on the success of Aveir to provide more
first-of-their-kind products in the future, revolutionizing how
abnormal heart rhythms are treated."
About Aveir VR
Abbott's Aveir™ single chamber (VR)
leadless pacemaker is approved for the treatment of patients in the
U.S. with slow heart rhythms. The world's only leadless pacemaker
with a unique mapping capability to assess correct positioning
prior to placement, Aveir VR is specifically designed to be
retrieved if therapy needs evolve.
For U.S. important safety information on the Aveir VR leadless
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1 Tested at VVIR 60 bpm, 2.5 V, 0.4 ms, 600 ohms at