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FDA Approves New Device for Adults with Severe and Persistent Asthma
Date:4/27/2010

SILVER SPRING, Md., April 27 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The Alair Bronchial Thermoplasty System is intended for patients ages 18 and older whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications.

The device is composed of a catheter with an electrode tip that delivers a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy.

Inflammation causes the airways of people who have asthma to swell and narrow, making breathing difficult. The Alair system treats asthma symptoms by using radiofrequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient's ability to breathe. To benefit, patients will require multiple sessions targeting different areas in the lungs.

"The approval of the Alair system provides adult patients suffering from severe and persistent asthma with an additional treatment option for a disease that is often difficult to manage," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.

The FDA based its appr
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SOURCE U.S. Food and Drug Administration
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