AtriCure Receives Expanded CE-Mark Indication for AtriClip® Devices for the Reduction of Stroke in Patients with Atrial Fibrillation
August 22 2024 - 8:00AM
Business Wire
Expanded indication based on an abundance of
clinical evidence for AtriClip Devices
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 an expanded
indication for the AtriClip® in CE-marked countries in Europe. The
product is now indicated for use in patients at high risk of
thromboembolism for whom left atrial appendage exclusion is
warranted.
The AtriClip family of devices are innovative solutions designed
to exclude, electrically isolate, and eventually eliminate the left
atrial appendage during cardiac surgery. The LAA is a major source
of blood clots in patients with Afib, and this expanded indication
is a result of a significant body of clinical evidence and
real-world experience that demonstrates a reduction in stroke
events for patients who receive an AtriClip device.
“This new indication is tremendous validation of our AtriClip
device,” said Michael Carrel, President and CEO of AtriCure. “With
over 550,000 patients successfully treated worldwide, we have seen
the impact that our devices have on patient care. The expanded
indication from the European Commission confirms our own clinical
evidence that strokes can be reduced in patients who are at high
risk of developing thromboembolism, and we continue to see strong
opportunity to grow adoption of mechanical appendage closure.”
Since the first AtriClip device was used in 2007, there have
been over 85 peer-reviewed studies published on both acute and
long-term safety and efficacy. This represents over 11,000 patients
who were studied across multiple geographies.
“I’ve been using AtriClip devices for over a decade and have
seen firsthand the benefits of its safety and efficacy,” said
Professor Dr. Med. Nicolas Doll, Chief Physician of Cardiac
Surgery, Schuechtermann-Clinic, Bad Rothenfelde, Germany. “The
devices are easy to use, and they provide patients with the benefit
of long-term prevention of stroke, which makes adoption of the
AtriClip an easy decision.”
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/20240822944439/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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