A neurostimulation device that offers sufferers from obstructive sleep apnoea (OSA) an alternative to continuous positive airway pressure (CPAP) therapy has gained CE Mark approval.
The Hypoglossal Nerve Stimulation (HGNS) system from US company Apnex Medical has been approved for sale in Europe based on the results of clinical studies in the US and Australia that showed the device to reduce the symptoms of OSA.
OSA – an inability to breathe during sleep – is estimated to affect 100 million people worldwide. It causes excessive daytime fatigue and increases the risk of stroke, heart disease and death.
CPAP therapy is the current standard for OSA, but many patients cannot tolerate it or comply poorly with it. The HGNS system offers a radically different approach: an implantable therapy that activates the muscles in the upper airway.
Implanted in the shoulder, the HGNS system measures the patient’s breathing during sleep and delivers mild electrical pulses to the hypoglossal nerve (which controls the tongue) to keep the airway open.
The system can be programmed to operate only when the patient is asleep, or be turned on and off with a hand-held switch.
The Apnex Clinical Study, a randomised clinical trial, is ongoing in the USA, Europe and Australia. It is designed to test the safety and effectiveness of the HGNS therapy in patients with OSA in whom CPAP therapy has not been effective.
“CE Mark approval is an important confirmation of the substantial benefits that patients receive from our HGNS therapy for obstructive sleep apnoea and is a key milestone for our company,” said Chas McKhann, President and CEO of Apnex Medical. “We are excited to bring this innovative new therapy to Europe.”
Based in Minnesota, USA, Apnex Medical specialises in innovative therapies for sleep-disordered breathing.