AtriCure, Inc. (Nasdaq: ATRC), a leader in innovative surgical treatments for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain, has announced regulatory approval from China’s National Medical Products Administration (NMPA) to market and sell its AtriClip® Left Atrial Appendage (LAA) Exclusion System.
The AtriClip device is designed to electrically isolate the left atrial appendage during cardiac surgery, crucial for reducing blood clot risks in Afib patients. This approval represents a significant milestone in AtriCure’s mission to enhance global access to life-saving Afib treatments.
“We are excited to bring our AtriClip devices to patients in China,” said Michael Carrel, President and CEO of AtriCure. “This approval underscores our commitment to expanding treatment options worldwide. With a strong foundation in surgical ablation devices, this step marks a pivotal moment in our global growth strategy.”
The approval is supported by extensive clinical data demonstrating the safety and efficacy of AtriClip devices, utilized in over 550,000 patients globally. AtriCure plans to collaborate with leading medical institutions in China to provide comprehensive training and support, ensuring high standards of patient care. The company also aims to introduce additional innovative products in partnership with Chinese regulatory authorities.
About AtriCure, Inc.
AtriCure, Inc. develops innovative technologies for treating Afib and related conditions, benefiting over 37 million people worldwide. Its Isolator® Synergy™ Ablation System is FDA-approved for persistent Afib treatment. AtriCure’s AtriClip® devices are globally recognized for LAA management, while Hybrid AF™ Therapy offers minimally invasive solutions for long-standing persistent Afib. The company’s cryoICE cryoSPHERE® probes provide pain relief in cardiac and thoracic procedures.
