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Asthmatx Positive Panel Outcome Good Sign for Pulmonology Companies

The FDA's Anesthesiology and Respiratory Device Panel delivered good news to the interventional pulmonology sector by issuing a positive recommendation for Asthmatx Inc.'s Alair Bronchial Thermoplasty System, a treatment for severe asthma. The positive news came nearly a year after the same panel voted not to recommend Emphasys Inc.'s lung airway valve as a treatment for emphysema.

Asthmatx Inc. executives undoubtedly felt pressure going into last month's hearing with the Food and Drug Administration's Anesthesiology and Respiratory Therapy Devices Panel, from which it sought a positive recommendation for its Alair bronchial thermoplasty system. Everything is at stake at these meetings: years of work; millions of venture capital dollars; the hopes and aspirations of employees who've toiled to develop a device to make sick people better. But the six-year-old start-up brought even more than the usual baggage to Rockville, MD. A negative recommendation from the panel might have been a serious blow to the interventional pulmonology industry that's been long on promise but short on results. (See "Devices Fill the Lung Space," START-UP, January 2006 Also see "Devices Fill The Lung Space " - Medtech Insight, 1 January, 2006..)

Nearly a year earlier, the same panel voted overwhelmingly, 13-2, to not recommend approval of Emphasys Medical's Zephyr bronchial valve,...

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