New asthma approval
April 28, 2010
A WORLD first radiofrequency
device has been approved by the
US Food and Drug Administration
for the treatment of severe and
persistent asthma in patients aged
upwards of 18 years.
The Alair Bronchial Thermoplasty
System works by delivering
electromagnetic energy directly to
the airways, via a catheter with an
electrode tip.
The radiofrequency energy heats
the lung tissue in a controlled
manner, which in turn reduces the
thickening and swelling of airway
muscles, allowing the patient to
breathe more easily.
Trials of the technology on 297
patients found that with multiple
sessions targeting different areas
in the lungs, the device reduced
the number of asthma attacks
suffered by patients.
Side effects of the Alair system
included asthma attacks,
wheezing, coughing up blood,
chest tightness and partially
collapsed lungs.
The FDA has stipulated that
Alair’s manufacturers Asthmatx
must follow many of the patients in
the first trial, and enrol 300 new
patients for a follow-up post
approval study of long term safety
and effectiveness, for a period of
no less than five years.
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