ABBOTT PARK, Ill., Aug. 30, 2021
/PRNewswire/ -- Abbott (NYSE: ABT) today announced late-breaking
data from the Amulet™ LAA Occluder IDE trial, a multi-center,
head-to-head study comparing the company's Amplatzer™ Amulet Left
Atrial Appendage (LAA) Occluder with the Watchman‡ device (Boston
Scientific) to treat patients with atrial fibrillation (AFib) at an
increased risk of stroke. The results of the trial show Abbott's
Amulet device was superior for the primary endpoint of LAA closure
and noninferior for the primary endpoints of safety and
effectiveness versus the comparator device.
The findings were presented today in a late-breaking Hot Line
session at ESC Congress 2021 organized by the European Society of
Cardiology and simultaneously published in Circulation. The
trial results supported the recent U.S. approval of Amulet.
The LAA is a small pouch connected to the upper left chamber of
the heart. For people with AFib, 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.
Abbott's Amulet device with Dual-Seal technology (a lobe to fill
the body of the LAA and a disc to close off the opening into the
LAA) offers immediate closure of the LAA, reducing the risk of
stroke and – unlike the study comparator device – immediately
eliminates the need for blood-thinning medication following
implant. Amulet Occluder also offers a wider range of sizes to help
physicians treat a broad range of patients and allows recapturing
and repositioning to ensure optimal placement.
"Atrial fibrillation cases have increased in recent years as the
world continues to age, making stroke risk more prevalent and
resulting in higher usage of blood-thinning medication that can
lead to bleeding and other complications," said Dhanunjaya Lakkireddy, M.D., Kansas City Heart
Rhythm Institute at HCA Midwest Health, who served as principal
investigator for the study. "Amulet demonstrated a clear benefit
for people suffering from atrial fibrillation who are at risk of
stroke and in need of LAA occlusion. The Amulet IDE trial data show
that we can effectively treat these patients with Amulet and get
them off blood thinners immediately following implantation."
A Strong Foundation of Clinical Evidence
IDE trial is the first multicenter, large-scale randomized study to
compare Abbott's Amulet device head-to-head with the Watchman
Results from the study demonstrated that Abbott's Amulet
Occluder with Dual-Seal technology:
- Was successfully implanted in 98.4% of patients compared to
96.4% of patients receiving the Watchman device.
- Demonstrated superiority for the primary endpoint of LAA
closure compared to Watchman (98.9% vs. 96.8%, p (superiority) =
- Was noninferior to the comparator device for the co-primary
safety endpoint (a composite of procedure-related complications,
all-cause death or major bleeding through 12 months) and co-primary
effectiveness endpoint (a composite of ischaemic stroke or systemic
embolism through 18 months).
Importantly for patients and their physicians, Amulet did not
require the use of blood thinners for participants following
implant in the study. Watchman patients were mostly (82%)
discharged on anticoagulant therapy (warfarin plus aspirin). In
contrast, only 20% of Amulet patients were discharged on
anticoagulants, and most (75.7%) were discharged on dual
antiplatelet therapy (clopidogrel plus aspirin).
"Now backed by the strength of the Amulet IDE data and the
ability to immediately close the LAA, our Amulet device has the
potential to change the way physicians approach LAA occlusion
therapy," said Michael Dale, senior
vice president of Abbott's structural heart business. "Offering
immediate, superior LAA closure allows Americans living with atrial
fibrillation to experience greater peace of mind against the worry
of having a stroke without the need for blood-thinning medication
immediately following the procedure."
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. Amulet is part of the Abbott Amplatzer family of products
with proven clinical success for more than two decades.
For U.S. important safety information on Amulet, visit:
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