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FDA Panel Vote on Valve Disappoints Emphasys

Nearly a decade into the race to arm pulmonologists with interventional tools to treat emphysema, no clear winner is emerging. Emphasys, which had led the pack in developing a bronchial valve, hit a wall at the FDA. The question is whether competitors can fill the gap.

Necessity may indeed be the mother of invention, but Emphasys Medical Inc. learned this month it’s not going to buy you a break with the Food & Drug Administration. An FDA review panel shocked the company and surprised competitors by voting not to recommend approval for Emphasys' Zephyr Endobronchial Valve. The negative vote—which typically is heeded by the full FDA--took down the leader of the pack of start-ups developing and testing devices to provide comfort for people suffering from the severest forms of emphysema. (See "Devices Fill The Lung Space," START-UP, January 2006 Also see "Devices Fill The Lung Space " - Medtech Insight, 1 January, 2006..)

Even though Emphasys’ product might have provided some relief to people suffering from the crippling pulmonary disease, 13 of the...

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