AtriCure Receives CE-Mark for the EnCompass® Clamp
01 10월 2024 - 9:00PM
Business Wire
Approval provides new catalyst for AtriCure’s
international growth
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 to sell the EnCompass® Clamp in CE-marked countries in the
European Union, and European surgeons have recently performed the
first series of cases with AtriCure’s EnCompass Clamp. The
EnCompass Clamp received FDA 510(K) clearance and was launched in
the United States in 2022.
“Launching our EnCompass Clamp in Europe represents a
significant expansion of our product line internationally,” said
Michael Carrel, President and CEO of AtriCure. “We have seen this
product have a positive impact in the United States over the last
two years by advancing treatment concomitant to cardiac surgery. We
are excited to offer this safe, innovative, and effective therapy
to patients and our physician partners in Europe.”
The EnCompass Clamp provides a simpler and faster approach to
ablating the heart in open-chest procedures, allowing physicians to
perform a comprehensive epicardial ablation of the left atrium in
just a few minutes. The EnCompass Clamp includes the features of
AtriCure’s existing Synergy™ Clamp family, such as parallel
closure, uniform pressure, and custom power using Synergy
radiofrequency (RF). The EnCompass Clamp also allows for easier
placement using a magnetic guide, which enables more efficient
procedures by minimizing tissue dissection. Further, the EnCompass
Clamp is designed to fit cardiac anatomy, supporting surgical
ablation in procedures where the atrium would normally not be
opened such as CABG and AVR. AtriCure estimates approximately
400,000 cardiac surgeries occur annually in the European Union.
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/20241001409853/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
AtriCure (NASDAQ:ATRC)
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부터 10월(10) 2024 으로 11월(11) 2024
AtriCure (NASDAQ:ATRC)
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부터 11월(11) 2023 으로 11월(11) 2024