Published on Jan 03, 2011 with 0 comment
The FDA has approved the first medical device that uses radio-frequency energy for the treatment of severe persistent asthma in 18-year-olds and older.
All patients with severe persistent asthma share one thing: the common finding of inflammation and swelling of the lining of the bronchial tubes. The subsequent reduction in the diameter of the breathing tubes leads to difficulty breathing and shortness of breath that is experienced with asthma.
This new device, called the Alair Bronchial Thermoplasty System, treats asthma symptoms by using radio-frequency energy to heat the lung tissue in a controlled manner.This attempts to reduce the thickness of the airway mucosa and the surrounding smooth muscle. To benefit from this treatment, patients require multiple sessions targeting different areas in the lungs. The device is composed of a catheter with an electrode tip that delivers a controlled amount of radiofrequency energy, directly to the airways. A controller unit, operated by the physician, generates and controls the energy.
The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The trial showed a reduction of severe asthma attacks in those treated with the device. The FDA is requiring a five-year post-approval study of the device to study its long-term safety and effectiveness.
It should be noted that this procedure, like all medical procedures, is not without risks. And, it will not be appropriate therapy for all severe asthmatics. This is a very exciting breakthrough in the treatment of refractory and severe asthma, but much more study and research is needed before allergists and pulmonologists will be referring their patients for this procedure.