The Alair™ System

Bronchial Thermoplasty (BT) delivered by the Alair System comprises 2 primary components, the Alair Catheter and the Alair Radiofrequency (RF) Controller.

Alair Catheter

The sterile, single-use, disposable device is designed with a proprietary set of control parameters and algorithms to deliver therapeutic RF energy to the airways via a standard bronchoscope.

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 Alair System – Alair Catheter

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:

  • Is reusable and provided non-sterile
  • 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
  • Automatically limits the energy delivered in any activation to a maximum of 120 joules
  • Includes safety algorithms that automatically shut off the RF Controller output in the event that atypical energy delivery is detected
  • 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

The Alair System – Alair Radiofrequency (RF) Controller

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.