Apnex Medical has gained CE Mark approval for its hypoglossal nerve stimulation system, used to treat patients with obstructive sleep apnoea.
The system is an implantable therapy that activates the upper airway muscles to make sure they remain open during sleep.
The European approval is backed by the two clinical studies, which demonstrated a reduction in obstructive sleep apnoea and improvements in a patient’s quality of sleep, quality of life and overall health.
Apnex Medical president and CEO Chas McKhann said the company is currently enrolling patients as part of a randomised clinical trial to further validate the safety and effectiveness of the hypoglossal nerve stimulation system in Australia, the US and selected countries in Europe.
The data from the trial will support the pre-market approval application to the US Food and Drug Administration.