Apnex Medical of St. Paul, Minn., has received CE mark approval to market its hypoglossal nerve stimulation (HGNS) system in Europe, after two clinical studies conducted in the U.S. and Australia.
HGNS is designed for use by people who suffer from obstructive sleep apnea (OSA), and the studies sought to assess improvements in patients' quality of sleep, quality of life and overall health, according to Apnex.
The HGNS system is an implantable therapy intended to work by activating muscles in the upper airway to ensure it remains open during sleep. The system detects a patient’s breathing pattern and delivers mild stimulation to the hypoglossal nerve timed with the breath, according to Apnex. The implant is programmed to work only during sleep and can be turned off or on with a handheld controller.
According to Chas McKhann, president and CEO of Apnex, the company is further evaluating the HGNS system clinical study. Data from the study are intended to support a premarket approval application for the system to the FDA.