FDA Approves RF Device for Chronic Asthma

Radio-frequency device approved by FDA.

The Alair Bronchial Thermoplasty System is the first device that uses radio-frequency energy to treat lung inflammation in patients with severe chronic asthma to be approved by the Food and Drug Administration.

The treatment is limited to those patients over 18 who cannot control their symptoms with medication.  This includes those patients using corticosteroids or a long acting beta agonist.

To receive the full benefit of the device, multiple sessions targeting different parts of the lungs are necessary.  It cannot be used by those who have implanted pacemakers or defibrillators.

There are potential side effects such as asthma attacks, chest pain or tightness, nausea, headache, coughing up blood, anxiety, wheezing, or a partially collapsed lung.

Using radio-frequency energy the device heats and reduces the thickness of lung tissue thus improving the patients ability to breathe.

The system was evaluated in a study which involved nearly 300 patients with severe and persistent asthma.  The approval is conditional stating that the manufacturer, Asthmatx Inc. must conduct additional studies to determine the device’s long-term safety and effectiveness.