The FDA cleared the first oral appliances for treating severe obstructive sleep apnea (OSA), Vivos Therapeutics announced on Wednesday.
The removable complete airway repositioning and/or expansion (CARE) line of oral appliances are an alternative treatment to continuous positive airway pressure (CPAP) or surgical neurostimulation implants for severe OSA, the company noted.
Supporting trial data involving 73 patients with severe OSA showed that 80% had an improvement of at least one OSA classification or a 50% or greater improvement in the Apnea Hypopnea Index with the devices. In addition, 97% of patients either improved or stayed the same. Average treatment time was 9.7 months.
“Make no mistake: this is a huge development on the landscape of treatments for OSA,” said David McCarty, MD, previously of Colorado Sleep Institute. “As the medical profession has gained a better understanding of the complex factors contributing to OSA, we now recognize that a critical component to this condition is the form and functionality of the oral vault.”
“This decision by the FDA could be life changing for patients who suffer from severe OSA and for whom other treatments have failed,” he added.
The agency had previously cleared the company’s daytime-nighttime (DNA) appliance for mild to moderate OSA in adults in January. The new clearance for severe OSA applies to the DNA appliance, the mandibular repositioning nighttime (mRNA) appliance, and the modified version of the mRNA (mmRNA). The oral appliances can be used along with positive airway pressure (PAP) and/or myofunctional therapy as needed.
Unlike other oral appliances on the market, the CARE appliances gradually reposition the hard and soft tissues that define the airway, thereby opening it up and optimizing its function and flow, Vivos explained.
No safety issues were observed, the company said, although some patients required aligners following treatment.