A meeting of the Anesthesiology and Respiratory Therapy Devices Panel was held on December 5, 2008. The Panel discussed the submission, made recommendations, and voted on the Premarket Approval Application (P070025) for the Emphasys Medical Inc. Zephyr Endobronchial Valve System.
The device consists of the valve, valve loader, and a delivery device. The valve consists of an implantable one-way valve mounted in a self-expanding stent structure that is covered with a membrane. It is implanted in the bronchial lumen via a working channel of a standard bronchoscope using a proprietary delivery system. Once implanted, the one-way valve is intended to prevent air flow into the hyperinflated regions of the lung distal to the valve, while allowing air flow out of the hyperinflated regions, to result in improved Forced Expiratory Volume in the first second ( FEV 1 ) and 6 minute walk test distance in patients with severe heterogeneous emphysema.
Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (11-2) that the application be found “not approvable.” The Panel believes that clinical studies did not demonstrate reasonable evidence of clinical effectiveness in the target population and that more long term effectiveness data are necessary. The Panel stated that the device may show promise for use in certain population subsets for which sufficient data were not available. The panel suggested further studies to adequately identify a potential subset population that may benefit from the device and to evaluate the safety and effectiveness of the device in such a population.
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