FDA Approves New Device for Adults with Severe and Persistent Asthma
The U.S. Food and Drug Administration has approved the first medical device that uses radio-frequency energy to treat severe and persistent asthma in certain adults.
Asthmatx’s Alair® Bronchial Thermoplasty System is intended for people 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 radio-frequency energy, directly to the airways.
The Alair system treats asthma symptoms by using radio-frequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways, and improving a person’s ability to breathe. To benefit, people will require multiple sessions targeting different areas in the lungs.
The FDA based its approval on data from a clinical trial of 297 people with severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system. The FDA is requiring a five-year post-approval study of the device to study its long-term safety and effectiveness.
This article was originally published in Coping® with Allergies & Asthma magazine, July/August 2010.