Merit Medical Systems, a US-based medical device company, has obtained approval from the Chinese Food and Drug Administration (CFDA) for its Aero tracheobronchial stent system.
The approval includes the over-the-wire system and also the direct visualization system. The approval is for a period of five years and covers 33 catalog items.
Merit Medical Systems chairman and CEO Fred Lampropoulos said that this approval is the company’s initial entry of its Endotek division into China.
"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," Lampropoulos added.
Merit Medical Systems owns and maintains the product licenses and the products will be distributed by a select group of dealers with support from the company’s marketing and clinical group.