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This article was originally published in The Gray Sheet

Executive Summary

Spiration IBV lung valve approved for post-surgical air leaks: Removable bronchial valve implant gains FDA humanitarian device exemption (HDE) approval Oct. 24 to treat prolonged air leaks that last at least seven days after a lobectomy, segmentectomy, or lung volume reduction surgery. The valve, which is inserted using a bronchoscope and intended to be removed within six weeks, allows air to flow in only one direction, preventing it from entering the affected areas but allowing air and mucus to escape, according to FDA. The device "may ease post-operative recovery," states Daniel Schultz, director of FDA's device center. The agency's HDE approval process is intended for devices that diagnose or treat conditions affecting less than 4,000 U.S. patients annually. Privately held, Redmond, Wash.-based Spiration notes that it also is conducting a pivotal study of the device for severe emphysema (1"The Gray Sheet" April 14, 2008, p. 10)
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