WEDNESDAY, April 28 (HealthDay News) -- The first device that uses radiofrequency energy to help control lung inflammation in adults with severe chronic asthma has been approved by the U.S. Food and Drug Administration.
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The Alair Bronchial Thermoplasty System is designed for people 18 and older whose asthma isn't controlled with medication, including inhaled corticosteroids or long-acting beta agonists.
The device delivers radiofrequency energy directly to the airways, heating and reducing the thickness of lung tissue and improving users' ability to breathe, the agency said in a news release.
To achieve the device's full benefit, users will require multiple sessions targeting different parts of the lungs.
The device was evaluated in a clinical study involving 297 people with severe and persistent asthma. As a condition of approval, California-based manufacturer Asthmatx Inc. must conduct additional studies to evaluate the product's long-term safety and effectiveness, the FDA said.
The device should not be used by people with an implanted pacemaker or defibrillator, the agency said.
-- Scott Roberts
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