AtriCure
(Nasdaq: ATRC)
announced today that its AtriClip system received approval from regulatory authorities in China.
The National Medical Products Administration (NMPA) of China approved several models of the left atrial appendage (LAA) exclusion system. AtriCure designed the device to exclude and electrically isolate the LAA during cardiac surgery. LAA can cause blood clots in patients with AFib, according to a news release.
AtriCure said that approval came on the back of clinical data demonstrating both the safety and efficacy of AtriClip. The devices have been successfully used in more than 550,000 patients around the world.
With the approval in China, AtriCure plans to partner with leading medical institutions and professionals to provide training and support. It also expects to work with Chinese regulatory authorities to facilitate the introduction of additional products in the future.
“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.”
Medtech companies across multiple markets are looking to establish footholds in China. Boston Scientific, Accuray, Medtronic and Intuitive all received approvals of technologies in recent months there.
