The Alair™ System
Bronchial Thermoplasty (BT) delivered by the Alair System comprises 2 primary components, the Alair Catheter and the Alair Radiofrequency (RF) Controller.
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:
- Catheter Shaft: The catheter shaft which is inserted through the working channel of a bronchoscope
- Catheter Handle: A handle that is used to control the deployment of the electrode array
- Proximal Catheter Shaft Mark: Notifies user when the catheter is about to exit the distal end of the bronchoscope
- Catheter Electrical Cable: An electrical cable that connects to the Alair RF Controller
- Electrode Array: An electrode array at the distal tip of the catheter consisting of 4 electrodes evenly spaced circumferentially
- 5 mm Electrodes: Exposed portions of the array that delivers RF energy
- 5 mm Catheter Shaft Marks: Measurement marks to assist in providing contiguous (adjacent but not overlapping) activations of the electrodes
- 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:
- 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
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.