AtriCure Gets Approval for AtriClip Sale in China

AtriCure has obtained regulatory approval from China’s National Medical Products Administration (NMPA) to market and sell several models of its AtriClip left atrial appendage (LAA) exclusion system.

AtriClip is used to exclude and electrically isolate the left atrial appendage during cardiac surgery. The LAA is a major source of blood clots in atrial fibrillation (AFib) patients.

The company said Chinese approval was based on clinical data showing AtriClip’s safety and efficacy. The devices have been successfully used in over 550,000 patients across the world.

AtriCure said it now plans to partner with leading medical institutions and professionals in China. It will offer comprehensive training and support, and work closely with Chinese regulatory authorities to facilitate introduction of future products.

“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.”

Earlier this year, AtriCure released its cryoSPHERE+ cryoablation probe to manage post-operative pain.