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Spiration, Inc. Receives First FDA Approval for Bronchial Valve

by Joan Trombetti, Writer | October 28, 2008

The IBV Valve System is currently under investigation in the U.S. as a new treatment option for the many people with severe emphysema who do not respond well to current medical therapies or are not eligible for or elect not to undergo invasive surgery such as lung volume reduction or lung transplantation. The device is marketed and distributed by Olympus in Europe, where the system has received market clearance through the CE Mark for the treatment of diseased and damaged lung, an indication that includes the treatment of emphysema and the resolution of prolonged air leaks. Olympus also has development and distribution rights for the IBV Valve System in Japan.

About Spiration, Inc.
Spiration, Inc. is committed to improving quality of life for patients with acute and chronic conditions of the lung through the development of novel therapies. Founded in 1999 in Redmond, Wash., the privately held company is backed by prominent investors including Three Arch Partners, New Enterprise Associates, Versant Ventures, New Leaf Ventures (Sprout Group), InterWest Partners, Investor Growth Capital, Saints Capital and Olympus Medical Systems Corp. For more information, visit the company's website at www.spiration.com.
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Information about the U.S. pivotal study of Spiration's IBV Valve System may be found at www.emphysematrial.com. SOURCE: Spiration, Inc.

Read the FDA announcement here:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01906.html

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