The Alair System

The Alair^® Bronchial Thermoplasty System is comprised of two primary components, the Alair^® Catheter and the Alair^® Radiofrequency (RF) Controller.

Alair^® Catheter

The Alair^® Catheter is a sterile, single-use, disposable device designed to be delivered through the working channel of a standard high-frequency compatible flexible bronchoscope. The purpose of the Alair^® Catheter is to deliver therapeutic RF energy to the airways.

The Alair^® Catheter consists of:

1. Catheter Shaft: The catheter shaft which is inserted through the working channel of a bronchoscope
2. Catheter Handle: A handle that is used to control the deployment of the electrode array
3. Proximal Catheter Shaft Mark: Notifies user when the catheter is about to exit the distal end of the bronchoscope
4. Catheter Electrical Cable: An electrical cable that connects to the Alair^® RF Controller
5. Electrode Array: An electrode array at the distal tip of the catheter consisting of 4 electrodes evenly spaced circumferentially
6. 5 mm Electrodes: Exposed portions of the array that delivers RF energy
7. 5 mm Catheter Shaft Marks: Measurement marks to assist in providing contiguous (adjacent but not overlapping) activations of the electrodes
8. 1.5 mm Atraumatic Distal Tip: Used to measure airway size for treatment

The electrode array has four stainless steel wire legs. Each leg is insulated, leaving a 5 mm long exposed area at the center of the leg that is the active electrode, or energy delivering region. Visual contrast between the insulation and the exposed active electrode provides visual feedback to the user during bronchoscopy.

Alair^® Radiofrequency (RF) Controller

The Alair^® RF Controller provides temperature-controlled delivery of RF energy to the Alair^® Catheter. RF technology has a long history of safe use for medical purposes.

The Alair^® RF Controller is designed with a proprietary set of control parameters and algorithms to deliver the correct intensity and duration of thermal energy sufficient to reduce the mass of airway smooth muscle tissue, while limiting long-term impact to surrounding tissues.

The Alair^® RF Controller:

1. Is reusable and provided non-sterile
2. Delivers low-power (18 watts maximum), temperature-controlled RF energy to the airway at a treatment temperature setting of 65°C for duration of 10 seconds
3. Automatically limits the energy delivered in any activation to a maximum of 120 joules
4. Includes safety algorithms that automatically shut off the RF Controller output in the event that atypical energy delivery is detected
5. Incorporates hardware and software that limit current, voltage, power and temperature at any time during an activation, as well as the total energy administered during each activation

Numerous safety features have been incorporated into the design of the Alair^® RF Controller and Alair^® Catheter to minimize the chance of unintended over-treatment. These features have been developed and tested through extensive pre-clinical studies.