Edwards' mitral heart valve wins Chinese SFDA nod

Edwards Lifesciences ($EW) earned Chinese regulatory approval for its long-selling mitral heart valve, representing a major win for the device company during its push to grow in an explosively expanding market.

China's State Food and Drug Administration signed off on the company's Carpentier-Edwards Perimount mitral heart valve, which is made of bovine pericardial tissue. Edwards has sold the product in the U.S. since 2000 and it has long been available in the European Union under a CE mark. Edwards says it first started using Perimount mitral heart valves in the clinic almost 30 years ago.

Edwards, like many device companies, has turned to China for new growth opportunities and the country factors into its long-term growth plans. Known for heart valves and hemodynamic monitoring devices, Edwards has also propelled U.S. growth with its Sapien transcatheter aortic heart valve, which won FDA approval earlier this fall to treat a larger class of patients.

Analysts and observers continue to speculate, however, that Edwards is an acquisition target. Transcatheter heart valve revenue has fallen short in the 2012 third quarter, and some see the company as facing problems with emerging competitors including Boston Scientific ($BSX), St. Jude Medical ($STJ) and Medtronic ($MDT).

- read the release

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