FDA approves "first ever" device for asthma
This article was originally published in Clinica
Executive Summary
Asthmatx's Alair asthma therapy has received premarket approval (PMA) from the US FDA. This makes it the "first ever non-drug treatment for asthma", the Sunnyvale, California company claims. Alair is intended for adults with severe asthma who are already taking the highest doses of conventional asthma drugs (inhaled corticosteroids and long-acting beta-agonists) with little success. The device performs bronchial thermoplasty – using thermal energy to reduce excess airway smooth muscle that is associated with bronchoconstriction. The approval follows a recommendation from an FDA advisory panel in October 2009 (www.clinica.co.uk, 29 October 2009). This was based on results from the AIR2 trial, which found that Alair led to a 32% reduction in severe asthma attacks.