The Alair® System

The Alair® System consists of a single-use catheter device and a controller that delivers radiofrequency energy during an outpatient bronchoscopic procedure known as Bronchial Thermoplasty. The Alair® System provides a different investigational treatment approach for asthma that uses radiofrequency energy to apply controlled heat to the airway wall to reduce the amount of airway smooth muscle and restrict its ability to narrow the airway.

The Alair® System from Asthmatx has been used in 16 patients with asthma who were enrolled in a safety trial at two asthma centers in Canada. Although still under clinical investigation, data on 16 patients after 2 year follow-up show less airway narrowing after stimulation with a drug that causes contraction of airway smooth muscle. Patients surveyed indicated that they would definitely or probably undergo the Bronchial Thermoplasty procedure again, knowing now what the procedure involves. In previous clinical studies conducted outside the US,(e.g. Canada, Brazil and Europe), more than 255 treatment bronchoscopies have been performed with this device in 86 patients with moderate to severe asthma. Of these patients, 86 are at least 24-months post-treatment as of October 2006.

CAUTION: The Alair® System is an Investigational device. It is limited by United States law to investigational use. To be used by Qualified Investigators only.