AtriCure Receives Regulatory Approval to Sell AtriClip® Devices in China
July 23 2024 - 8:00AM
Business Wire
AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical
treatments and therapies for atrial fibrillation (Afib), left
atrial appendage (LAA) management, and post-operative pain
management, today announced that it has received regulatory
approval from the National Medical Products Administration (NMPA)
of China to market and sell several models of its AtriClip® Left
Atrial Appendage (LAA) Exclusion System.
The AtriClip device is an innovative solution designed to
exclude and electrically isolate the left atrial appendage during
cardiac surgery. The LAA is a major source of blood clots in
patients with Afib, and this approval marks a significant milestone
in AtriCure’s mission to provide life-saving treatments for
patients suffering from Afib and associated risks.
“We are committed to expanding access to treatment and enhancing
patient outcomes globally and are thrilled to receive approval to
treat patients with our AtriClip devices in China,” said Michael
Carrel, President and CEO of AtriCure. “While patients have been
benefitting from our surgical ablation devices in China for many
years, this is a major step forward in our global expansion
strategy. China represents a significant market opportunity, and we
look forward to working with our partners and healthcare providers
across the country to deliver our innovative solutions.”
The approval of the AtriClip device in China is based on robust
clinical data demonstrating its safety and efficacy. AtriClip
devices have been successfully used in over 550,000 patients
worldwide and are recognized for a unique design, which ensures
complete exclusion, and eventual elimination of the LAA via the
process of ischemic necrosis. With this approval, AtriCure plans to
partner with leading medical institutions and professionals in
China to provide comprehensive training and support, ensuring the
highest standards of patient care. The company will also work
closely with Chinese regulatory authorities to facilitate the
introduction of additional innovative products in the future.
For more information about the AtriClip line of products, visit
www.atricure.com/laa-exclusion.
Forward-Looking
Statements
This press release contains “forward-looking statements”– that
is, statements related to future events that by their nature
address matters that are uncertain. Actual results could differ
materially. For details on the uncertainties that may cause our
actual results to be materially different than those expressed in
our forward-looking statements, visit
http://www.atricure.com/forward-looking-statements as well as our
Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q
which contain risk factors. We assume no obligation to update any
forward-looking statements contained in this release and the
related attachment as a result of new information or future events
or developments, except as may be required by law.
About AtriCure
AtriCure, Inc. provides innovative technologies for the
treatment of Afib and related conditions. Afib affects more than 37
million people worldwide. Electrophysiologists, cardiothoracic and
thoracic surgeons around the globe use AtriCure technologies for
the treatment of Afib, reduction of Afib related complications and
post-operative pain management. AtriCure’s Isolator® Synergy™
Ablation System is the first medical device to receive FDA approval
for the treatment of persistent Afib. AtriCure’s AtriClip® Left
Atrial Appendage Exclusion System products are the most widely sold
LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is
a minimally invasive procedure that provides a lasting solution for
long-standing persistent Afib patients. AtriCure’s cryoICE
cryoSPHERE® probes are cleared for temporary ablation of peripheral
nerves to block pain, providing pain relief in cardiac and thoracic
procedures. For more information, visit AtriCure.com or follow us
on X (formerly Twitter) @AtriCure.
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version on businesswire.com: https://www.businesswire.com/news/home/20240723273609/en/
Angie Wirick Investor Relations Chief Financial Officer (513)
755-5334 awirick@atricure.com
Valerie Storch-Willhaus Media Relations Vice President,
Corporate Marketing & Communications (612) 605-3311
vstorch-willhaus@atricure.com
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