Brief Statement of Relevant Indications for Use, Contraindications, Warnings, and Adverse Events: The Alair™ Bronchial ThermoplastySystem is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Alair System is not for use in patients with an active implantable electronic device or known sensitivity to medications used in bronchoscopy. Previously treated airways of the lung should not be retreated with the Alair System. Patients should be stable and suitable to undergo bronchoscopy. The most common side effect of BT is an expected transient increase in the frequency and worsening of respiratory-related symptoms. ENDO-551804-AA
As with any procedure, there are risks, and individual results may vary. The most common adverse event of BT is a temporary worsening of respiratory-related symptoms. These events typically occur within one day of the BT procedure and usually resolve within a week with standard care. There is a small risk (3.4% per procedure) that symptoms may require hospitalization.1
Castro M, et al, for the AIR2 Trial Study Group. Am J Respir Crit Care Med. 2010;181:116-124.