Merit Medical (NSDQ:MMSI) said today that its Endotek division will make a 1st foray into the Chinese medical device market, after regulators there approved its Aero tracheobronchial stent.
South Jordan, Utah-based Merit said the Chinese Food & Drug Administration granted a 5-year approval for the Aero system, including its over-the-wire deployment and direct visualization systems.
"This approval is our initial entry of Merit’s Endotek division into China," chairman & CEO Fred Lampropoulos said in prepared remarks. "The Aero stent product line has become the market leader in many areas of the world. Our hope is that we will have the same result in China."
Merit said it plans to use "a select group of dealers" to distribute the Aero system in the People’s Republic, "with support from Merit’s marketing and clinical group."
In March, Merit was caught up in the recall of 1% lidocaine HCl injections manufactured by Hospira (NYSE:HSP), after the FDA declared the recall Class I, which were included in procedural trays and kits made by Merit.