- Status -
- Type -
- Pre-PASC consultation -
- Pre-MSAC consultation -
- Outcome -
Application details
Reason for application
New MBS item.
Service or technology in this application
The Genio system is a medical device for the treatment of obstructive sleep apnoea (OSA). It has two key components:
- The Genio implantable stimulator – This device is implanted on the hypoglossal nerve during a surgical procedure of approximately 90 minutes.
- The Activation Chip & Disposable Patch – The activation chip contains a rechargeable battery and activates the Genio implantable stimulator by wireless energy transmission while the patient is asleep.
The Genio system is designed to treat moderate to severe OSA patients via hypoglossal nerve stimulation. The hypoglossal nerve is the main nerve controlling tongue movement. Direct stimulation of this nerve moves the tongue forward and increases pharyngeal muscles tone. In turn, this prevents the collapse of the airway and maintains breathing space for the patient.
Type: Therapeutic
Medical condition this application addresses
OSA is a sleep condition where the muscles and soft tissues in the throat and tongue relax too much and collapse. This leads to repeated episodes of obstruction of the airway and cessation of breathing during sleep, in turn resulting in a reduction in blood oxygen saturation. Common symptoms of OSA are daytime sleepiness, restless sleep and loud snoring. Patients with OSA also have an increased risk of insulin resistance (Type 2 diabetes), dyslipidaemia, vascular disease and death.
Application documents
Application form
Consultation survey
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Meetings to consider this application
- PASC meeting: Expedited – bypassing PASC
- ESC meeting: -
- MSAC meeting: -