The DNA appliance is said to provide a new treatment option for mild-to-moderate OSA, by expanding the palate to clear the airway, training the tongue to rest in the proper position, and shifting patients from nasal to oral breathing
FDA Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia)
Vivos Therapeutics has received the US Food and Drug Administration (FDA) 510(k) approval for its DNA oral appliance to treat obstructive sleep apnea (OSA) and snoring in adults.
The medical device company has been offering DNA appliances for several years for orthodontic treatment such as the expansion of the jaw and positioning of teeth in adults and children.
The current FDA approval of DNA appliance as a Class II medical device is said to provide a new treatment option for mild-to-moderate OSA.
The new treatment would expand the palate to clear the airway, train the tongue to rest in the proper position, and shifts patients from nasal to oral breathing, said the company.
Vivos chairman and chief executive officer Kirk Huntsman said: “For the first time, the FDA has formally recognised the benefits of our proprietary core technology in our DNA appliance as an effective treatment for mild-to-moderate OSA in adults.
“The FDA now joins other international regulatory bodies in recognising 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.”
Currently, OSA can be treated through continuous positive airway pressure (CPAP), mandibular advancement devices (MAD), and surgical intervention.
CPAP are uncomfortable to wear and challenging to transport, MADs cause discomfort as they move the jaw forward, and most people do not opt for surgical procedures.
Vivos said that the DNA appliance when combined with associated protocols as part of the Vivos Method, will offer a new treatment option.
The Vivos Method includes the Vivos Complete Airway Repositioning and Expansion (CARE) appliance therapy and associated protocols.
The method would alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and palate, which is the root cause of snoring and OSA.
Vivos has submitted clinical data related to DNA to the FDA, as part of the regulatory process, which included pre- and post-treatment Apnea Hypopnea Index (AHI) scores.
The data showed that 28% of patients had their OSA resolved, and 63% of patients improved by one AHI classification, between severe, moderate, mild, and no OSA.
It also showed that 86% of patients improved their airway size, and 97% of patients increased the width of their palate, which allowed proper positioning of their tongue while at rest.
Furthermore, the appliance can be used together with other treatment modalities such as myofunctional therapy or CPAP, said the medical device company.