European Nod for HG Nerve Stimulation in Sleep Apnea

Yael Waknine

October 27, 2011

October 27, 2011 — The European Commission has approved an implantable hypoglossal nerve stimulation (HGNS) system (Apnex Medical, Inc), granting the device the Conformité Européenne Mark for the treatment of obstructive sleep apnea (OSA).

When activated, the respiration-sensing lead monitors the patient's breathing, activating the neurostimulator as needed. The stimulation lead then delivers therapy to the hypoglossal nerve, which controls tongue muscles, thereby ensuring airway patency during sleep.

European approval was based on data from 2 clinical studies conducted in the United States and Australia that revealed significant reductions in OSA, as well as substantial improvements in quality of sleep, quality of life, and overall health.

The Conformité Européenne Mark "approval is an important confirmation of the substantial benefits that patients receive from our HGNS therapy for [OSA]," said Chas McKhann, Apnex Medical president and chief executive officer, in a company news release.

"We are excited to bring this innovative new therapy to Europe. We are also focusing on further evaluation of the HGNS System in the Apnex Clinical Study, a randomized clinical trial of the HGNS system that is enrolling patients in the United States, Australia and in select countries in Europe," he added.

The data are intended to support a premarket approval application to be filed with the US Food and Drug Administration.

To be eligible for the study, individuals must be aged 21 to 80 years, suffer moderate or severe OSA that is refractory to continuous positive airway pressure therapy, have a body mass index of 35 kg/m2 or less, and be in general good health.

Potential study participants can obtain additional information by calling 1-888-975-3370 or visiting the trial's Web site.

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