Bronchial thermoplasty, a novel therapy option for severe asthma because of limitations of existing medications, there remains a significant unmet medical need to improve the care for patients with severe asthma, by better controlling their asthma symptoms. Bronchial thermoplasty (BT), delivered by the Alair™ System, is a long-lasting treatment option for this well-defined patient population. BT is a non-drug procedure for severe asthma in patients 18 years and older. This minimally invasive procedure is expected to complement conventional asthma drug treatments, thereby improving symptom control and the quality of life of patients with severe asthma. Benefit of reducing airway smooth muscle the new Alair™ Bronchial Thermoplasty System is designed to help control asthma by reducing the mass of airway smooth muscle (ASM). ASM is located within the walls of the airways in the lung and there is typically an increase in the amount of ASM in the lungs of patients with asthma. Although current medications are successful in controlling inflammation and contraction of ASM in most patients with asthma, some patients with severe asthma continue to suffer from excessive bronchoconstriction that plays an integral role in asthma attacks. Reducing ASM decreases the ability of the airways to constrict, thereby reducing the frequency and severity of asthma symptoms.

Treatment performed over three procedures BT is performed using the Alair™ System in three procedure visits, each scheduled approximately three weeks apart. The first procedure treats the airways of the right lower lobe, the second treats the airways of the left lower lobe and the third and final procedure treats the airways in both upper lobes. Each session lasts about one hour and following a brief period of recovery from the moderate sedation, the patient can go about their everyday activities at home.

The Alair™ Bronchial Thermoplasty System consists of two parts The Alair™ Bronchial Thermoplasty System, which is comprised of two primary components, delivers thermal energy to the airway wall, heating the tissue in a controlled manner to reduce ASM mass.
1. The Alair™ Bronchial Thermoplasty Catheter is a single-use device designed to be delivered via a standard bronchoscope through the nose or mouth. The catheter delivers radiofrequency energy along the length of the airway walls in a controlled ten-second burst, causing a reduction in the excessive ASM that narrows the airways in patients with asthma.

2. The Alair™ Bronchial Thermoplasty Radiofrequency (RF) Controller is designed with a set of control parameters and algorithms to deliver the correct intensity and duration of thermal energy sufficient to reduce the mass of ASM tissue, while limiting long-term impact to surrounding tissues.