ABBOTT PARK, Ill., Aug. 16, 2021
/PRNewswire/ -- Abbott (NYSE: ABT) today announced that the
U.S. Food and Drug Administration (FDA) approved the company's
Amplatzer™ Amulet™ Left Atrial Appendage Occluder to treat people
with atrial fibrillation (AFib) who are at risk of ischemic stroke.
The device offers immediate closure of the left atrial appendage
(LAA) – an area where blood clots can form in people suffering from
AFib – reducing their risk of stroke and immediately eliminating
the need for blood-thinning medication.
The LAA is a small pouch connected to the upper left chamber of
the heart. For people with AFib – the most common of the persistent
arrhythmias, or irregular heartbeats – the heart's ability to
effectively pump blood can be disrupted, allowing blood to pool and
collect in the LAA causing an increased risk for clotting. If clots
reach the blood stream, they can travel to the brain and cause a
stroke. For patients with AFib who are unable to take
blood-thinning medication long term, physicians may opt for
occlusion (or closure) of the LAA through a minimally invasive
procedure using devices like Abbott's Amulet to seal off the LAA
entirely and reduce the risk of stroke.
"As the world's population continues to age, we're seeing a
surge in atrial fibrillation cases, and with that comes increased
risk of stroke," said Dhanunjaya
Lakkireddy, M.D., Kansas City Heart Rhythm Institute at HCA
Midwest Health, who served as principal investigator for the study
that led to FDA approval. "The approval of Abbott's Amulet device
provides physicians with a treatment option that reduces the risk
of stroke and eliminates the need for blood-thinning medication
immediately after the procedure, which is incredibly valuable given
the bleeding risks associated with these medicines."
Before this approval, the only minimally invasive option for LAA
occlusion for U.S. physicians and their patients was a solution
with a single component to seal the LAA that requires
blood-thinning drugs to heal and additional patient monitoring to
ensure closure. In contrast, Abbott's Amulet uses dual-seal
technology to completely and immediately seal the LAA. Amulet
recipients do not need to use blood-thinning medication following
the procedure. Additionally, the device can treat a broad range of
anatomies and has the widest range of occluder sizes on the market;
it is also recapturable and repositionable to ensure optimal
placement.
"Amulet's unique dual-seal approach has made it the number one
LAA closure product in Europe, so
today's device approval by the FDA is an important milestone in
allowing us to bring this treatment option to American physicians
and patients," said Michael Dale,
senior vice president of Abbott's structural heart business.
"Consistent with our mission purpose, our minimally invasive Amulet
procedure for reducing stroke risk in patients with atrial
fibrillation will help people live better lives through better
health."
About Amplatzer Amulet
The Amplatzer Amulet LAA
Occluder has been approved for use in more than 80 countries,
including in Europe, Canada and Australia, since its initial CE Mark approval
in 2013. The FDA approval is supported by findings from the Amulet
IDE trial, a large-scale randomized head-to-head study comparing
Amulet with an alternative minimally invasive LAA occlusion device,
which will be virtually presented at the European Society of
Cardiology (ESC) 2021 Congress on August 30,
2021.
For U.S. important safety information on Amulet, visit:
https://abbo.tt/AmuletISI.
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 109,000 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.
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SOURCE Abbott