FDA Approves New Device for Obstructive Sleep Apnea

According to an announcement from Nyxoah, the Food and Drug Administration (FDA) has approved the use of the Genio system (Nyxoah, Mont-Saint-Guibert, Belgium) for the treatment of adults with moderate to severe obstructive sleep apnea (OSA). The approval provides a new treatment option for people with an apnea-hypopnea index (AHI) between 15 and 65.

The Genio system consists of a small implant placed in the chin region and an external wearable device that powers and controls the implant. This device delivers bilateral stimulation to both branches of the hypoglossal nerve to contract the tongue muscles without the need for an implanted battery. The external controller can be upgraded without surgery, and patients can adjust settings, pause or resume therapy, and track progress via a smartphone app. The system is also fully compatible with both 1.5T and 3T MRI.

The FDA’s decision was based on evidence from the multicenter, open-label DREAM trial (NCT03868618), which enrolled 115 patients with OSA:

• The study met its primary endpoint, with an AHI responder rate of 63.5% (P=.002) and oxygen desaturation index (ODI) responder rate of 71.3% (P<.001).
• There was a median 12-month AHI reduction of 70.8%, with reductions seen in both supine (66.6%) and non-supine (71.0%) positions.
• 82% of participants achieved an AHI below 15 at 12 months.
• 11 serious adverse events were reported, 3 of which were device related.