AtriCure Receives CE-Mark for the EnCompass® Clamp

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241001409853/en/