AtriCure 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 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 atrial fibrillation (AF), and this approval marks a significant milestone in AtriCure’s mission to provide life-saving treatments for patients suffering from AF and associated risks, the company said in a press release.
“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 clinical data demonstrating its safety and efficacy. AtriClip devices have been successfully used in over 550,000 patients worldwide and are recognised 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.
