AtriCure Receives Expanded CE-Mark Indication for AtriClip® Devices for the Reduction of Stroke in Patients with Atrial Fibrillation

Expanded indication based on an abundance of clinical evidence for AtriClip Devices

MASON, Ohio--(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 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.