Edwards LifeSciences: Sapien panel date set for July 20 - MassDevice

Edwards LifeSciences: Sapien panel date set for July 20 - MassDevice: "Edwards Lifesciences Corp. (NYSE:EW) will get its much-anticipated date with the FDA for its flagship Sapien transcatheter heart valve device on July 20. The federal watchdog agency's circulatory system devices advisory panel will review the company's pre-market approval application for the Sapien system. If it gets a green light from the panel, it should gain approval from the watchdog agency for commercial sale in the U.S., possibly by the end of the summer (the FDA is not bound by its advisory panels' recommendations, but usually follows their guidance). Edwards filed its PMA application in October 2010 and has staked its flag on an October 2011 release, sinking about $40 million into a launch that CEO Michael Mussallem said will allow the company to compete in 200 to 400 centers in the U.S."