Circulatory System

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)..

Source: http://www.massdevice.com/news/edwards-lifesciences-sapien-heart-valve-gets-july-fda-panel-date