Asthmatx, a developer of bronchial thermoplasty with the Alair System, has reported the publication of positive results from its pivotal study, the Asthma Intervention Research 2 (AIR2) Trial, in the American Journal of Respiratory and Critical Care Medicine (AJRCCM).
Asthmatx develops catheter-based medical devices for the treatment of asthma. The company has developed the Alair System to perform an investigational outpatient procedure known as bronchial thermoplasty. The Alair System has received a CE Mark for use in the European Union.
The AIR2 trial demonstrated reductions in asthma attacks (severe exacerbations) and emergency room visits for respiratory symptoms, as well as improvements in quality of life in adults with severe asthma who underwent bronchial thermoplasty with the Alair System.
The report in AJRCCM concluded that the increased risk of adverse events in the short-term following the Bronchial thermoplasty procedure is outweighed by the benefit of bronchial thermoplasty that persists for at least one year.
In October of 2009, the Anesthesiology and Respiratory Therapy Devices panel of the Medical Devices Advisory Committee to the FDA voted to recommend that the Alair System be found approvable with conditions based on the results of this and other studies. The application for FDA approval of the Alair System is presently under review by FDA.
Bronchial thermoplasty is a bronchoscopic procedure for the treatment of severe persistent asthma in patients of 18 years and older, whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists. Bronchial thermoplasty is performed through the working channel of a flexible bronchoscope that is introduced through a patient’s nose or mouth, and into their lungs.