Emphasys’ Endobronchial Valve For Emphysema Is “Not Approvable” – Panel
This article was originally published in The Gray Sheet
Executive Summary
Emphasys Medical's Zephyr endobronchial valve shows promise as a treatment for severe heterogeneous emphysema but lacks sufficient efficacy data to merit FDA approval, the agency's Anesthesiology and Respiratory Therapy Devices panel determined in an 11-2 vote Dec. 5
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Research In Brief
Zephyr data published: Pivotal data from the unsuccessful PMA review of the Zephyr endobronchial valve for advanced emphysema patients was published Sept. 23 in the New England Journal of Medicine. As presented to a 2008 FDA advisory panel, the device showed a "modest" advantage in the six-month primary endpoints for improvement in forced-expiratory-volume and six-minute-walk tests compared to standard medical care, but was also associated with more frequent complications including exacerbations of chronic obstructive pulmonary disease and hemoptysis in a 321-pateint randomized trial. The panel said more long-term assurance of device effectiveness was needed to balance the risks, and also pointed to numerous protocol violations and data gaps as cause for concern (1"The Gray Sheet" Dec. 15, 2008). In an editorial accompanying the NEJM paper, Antonio Anzueto, a pulmonologist at the University of Texas, agreed that there were several significant lapses in study implementation, including a "lack of standardization of concomitant medical therapy in both study groups." He concluded that it is "premature to recommend routine use" of endobronchial valves. Pulmonx acquired the Zephyr valve from the now-defunct Emphasys Medical in 2009 and is selling the product outside the U.S. (2"The Gray Sheet" May 18, 2009)
Research In Brief
Zephyr data published: Pivotal data from the unsuccessful PMA review of the Zephyr endobronchial valve for advanced emphysema patients was published Sept. 23 in the New England Journal of Medicine. As presented to a 2008 FDA advisory panel, the device showed a "modest" advantage in the six-month primary endpoints for improvement in forced-expiratory-volume and six-minute-walk tests compared to standard medical care, but was also associated with more frequent complications including exacerbations of chronic obstructive pulmonary disease and hemoptysis in a 321-pateint randomized trial. The panel said more long-term assurance of device effectiveness was needed to balance the risks, and also pointed to numerous protocol violations and data gaps as cause for concern (1"The Gray Sheet" Dec. 15, 2008). In an editorial accompanying the NEJM paper, Antonio Anzueto, a pulmonologist at the University of Texas, agreed that there were several significant lapses in study implementation, including a "lack of standardization of concomitant medical therapy in both study groups." He concluded that it is "premature to recommend routine use" of endobronchial valves. Pulmonx acquired the Zephyr valve from the now-defunct Emphasys Medical in 2009 and is selling the product outside the U.S. (2"The Gray Sheet" May 18, 2009)
Emphasys On The Block After FDA Panel Rejection Of Pulmonary Valve
The end is near for Emphasys Medical. At the end of March, the company's ongoing business and assets will be put up for auction, serving as a disappointing end to the firm's nine-year effort to get its Zephyr Endobronchial Valve to market