FDA grants 510(k) clearance to obstructive sleep apnea treatment device

The FDA has granted 510(k) clearance to a daytime-nighttime appliance, or DNA, to treat patients with mild to moderate obstructive sleep apnea, according to a manufacturer-issued press release.

According to the release, the proprietary DNA appliance (Vivos Therapeutics) is a class II device that provides a new treatment option for patients with OSA other than continuous airway pressure, mandibular advancement devices or surgical intervention, although it can also be used in conjunction with other treatment modalities.

This device is part of a treatment regimen known as The Vivos Method, which aims to address snoring and/or OSA by opening a patients’ airway through lengthening the palate and teaching the tongue to lay in an appropriate position, allowing the patient to breath from their nose rather than their mouth.

Before receiving this clearance, the DNA appliance was advertised as an orthodontic treatment.

The current clearance was based, in part, on data that reported pre- and post-treatment Apnea Hypopnea Index (AHI) scores when the device was not in the patients’ mouth, which is significant because other OSA treatments take measurements while the patient is using the device, according to the release. These data included that:

• “28% of patients had their OSA resolved;
• 63% of patients improved by one AHI classification (ie, severe to moderate, moderate to mild or mild to no OSA);
• 86% of patients improved their airway size; and
• 97% of patients increased the width of their palate which allows the tongue to rest in proper position, thus avoiding a potential airway obstruction.”

These outcomes usually remained after stopping treatment and may be permanent, the release said.

The FDA previously cleared two other class II devices from Vivos Therapeutics for OSA: mRNA (mandibular Repositioning Nighttime Appliance) and mmRNA (modified mandibular Repositioning Nighttime Appliance).

“This clearance is the culmination of years of pioneering clinical work,” Kirk Huntsman, Vivos’ chairman and CEO, said in the release. “For the first time, the FDA has formally recognized the benefits of our proprietary core technology in our DNA appliance (without mandibular advancement) as an effective treatment for mild to moderate OSA in adults. The FDA now joins other international regulatory bodies in recognizing the efficacy of our patented technology in the reduction and resolution of many of the symptoms of OSA that result from a lack of development of the jaws and oral cavity. We believe the DNA treatment can be life changing for many OSA patients, and we look forward to continued market adoption of our expanded menu of treatments for this debilitating condition.”