- First and only steerable delivery system designed to help seal
the left atrial appendage (LAA) in people with atrial fibrillation
who are at an increased risk of stroke
- Now available in the U.S., Abbott's steerable sheath offers
precise and flexible placement when used with the company's
Amplatzer Amulet LAA Occluder
ABBOTT
PARK, Ill., April 28,
2022 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced U.S. availability of its Amplatzer™ Steerable Delivery
Sheath, which is used with the company's Amplatzer Amulet™ Left
Atrial Appendage (LAA) Occluder to treat people with atrial
fibrillation (AFib) who are at risk of ischemic stroke. The latest
addition to Abbott's comprehensive structural heart portfolio, this
first-of-its kind delivery system demonstrates the company's
commitment to innovating across heart conditions, including in LAA
occlusion (closure).
The LAA is a small pouch connected to the upper left chamber of
the heart. The most common persistent arrhythmia, or irregular
heartbeat, AFib disrupts the heart's ability to effectively pump
blood. If this condition is left untreated, blood can pool and
collect in the LAA and increase the likelihood of a clot forming
and traveling to the brain to cause a stroke. For patients with
AFib who are unable to take blood-thinning medication long term,
physicians may opt for a minimally invasive procedure using devices
like Abbott's Amulet to seal off the LAA entirely and reduce the
risk of stroke.
"Since its FDA clearance last year, doctors have been utilizing
Abbott's Amulet device to help patients reduce their risk of stroke
from atrial fibrillation without the need for blood-thinning
medication," said Vivek Y. Reddy,
M.D., director of electrophysiology, Mount Sinai Hospital, who
completed the first U.S. procedure with the delivery system. "With
the Amplatzer Steerable Delivery Sheath, U.S. physicians now have
more flexibility and precise placement when implanting the Amulet
device, in simple and complex anatomies. It allows doctors to close
left atrial appendages in challenging cases, when otherwise it
might not be possible."
About Amplatzer Amulet and the Steerable Delivery
Sheath
Abbott's Amulet with dual-seal technology (consisting
of a lobe or piece to fill the cavity of the LAA and a disc to
close off the opening into the LAA) offers immediate and complete
closure of the LAA. This reduces the risk of stroke and – unlike
competitive devices – does not require blood-thinning
medication following the procedure, which is significant since
these medicines often carry bleeding risks.
To improve physician ease-of-use when implanting the Amulet
device, the Amplatzer Steerable Delivery Sheath features
bi-directional steering and an "auto-lock" function that provides
confidence the sheath will remain in its desired position. The
delivery system also includes a valve designed to stabilize blood
flow and minimize blood loss during the procedure.
Strong Clinical Evidence for Amplatzer Amulet
The
availability of the Steerable Delivery Sheath follows recent
back-to-back achievements for Abbott's LAA offering, including:
- Strong clinical evidence from the Amulet IDE trial, the
largest randomized LAA occlusion study to date, confirmed that the
Amplatzer Amulet offers durably superior LAA closure compared with
the Watchman‡ device (Boston Scientific) at 45 days (presented at
ESC Congress 2021) as well as at 12 months (presented at the
33rd Transcatheter Cardiovascular Therapeutics (TCT)
annual scientific symposium in 2021).
- Analysis presented at the International Stroke Conference 2022
demonstrated that device-related adverse events (peri-device leak
and device-related thrombus) were seen more frequently in the
Watchman device than Amulet.
- Data presented at TCT in 2021 confirmed the advantage of
Amplatzer Amulet vs. Watchman (including Watchman FLX) in relation
to the rate of occlusion of the LAA (SWISS-APERO), and peri-device
leak with Amulet at both the disc and the lobe was lower than
Watchman FLX (SEAL FLX).
"The Amulet LAA Occluder and Amplatzer Steerable Delivery Sheath
are examples of Abbott's commitment to helping people with
structural heart diseases live their best lives, and we remain
committed to the continued innovation of our technology for the
benefit of physicians and patients worldwide," said Michael Dale, senior vice president of Abbott's
structural heart business. "Abbott is focused on advancing
technology for LAA occlusion devices as well as how they are
delivered to optimize the physician experience and improve outcomes
for patients."
Abbott's Amplatzer Steerable Delivery Sheath is approved in
Europe and Canada and cleared for use in the U.S.
Receiving initial CE Mark approval in 2013, the Amplatzer Amulet
LAA Occluder has been approved for use in more than 80 countries
and is the market leader in Europe, the Middle
East and Asia.
For U.S. important safety information on the Amplatzer Steerable
Delivery Sheath, visit https://abbo.tt/SS_ISI.
For U.S. important safety information on the Amplatzer Amulet
LAA Occluder, 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
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.
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third-party trademark, which is property of its
respective owner.
© 2022 Abbott. All Rights Reserved.
View original
content:https://www.prnewswire.com/news-releases/abbott-strengthens-left-atrial-appendage-closure-leadership-with-us-availability-of-amplatzer-steerable-delivery-sheath-for-the-companys-amulet-device-301535302.html
SOURCE Abbott