AtriCure Receives Regulatory Approval to Sell AtriClip® Devices in China

AtriCure Press Release

MASON, Ohio -- AtriCure, Inc. a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, 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.

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.