On Sept. 18, 2024, Vivos Therapeutics introduced it acquired FDA 510(okay) clearance for its oral equipment to deal with reasonable to extreme obstructive sleep apnea (OSA) and loud night breathing in kids.
About Vivos’ DNA equipment
Vivos’ DNA equipment is an intraoral system designed to scale back loud night breathing and deal with reasonable to extreme OSA in kids aged 6 to 17. It consists of both an higher tray, decrease tray or each, and is designed to open the airway throughout sleep. It’s meant for pediatric sufferers identified with loud night breathing and/or OSA who additionally require orthodontic remedy. The system is personalized to the affected person.
The FDA approval is predicated on outcomes of a potential research in pediatric sufferers that demonstrated diminished sleep-related respiratory dysfunction signs, decreased loud night breathing and enchancment in apnea-hypopnea index (AHI) measurements.
Based on the corporate’s press launch, that is the primary time an oral medical system has been authorized to deal with reasonable to extreme OSA in kids.
The DNA equipment is a part of Vivos’ full airway repositioning and/or growth (CARE) line of OSA remedy home equipment. In Nov. 2023, Vivos Therapeutics acquired FDA 510(okay) clearance for its line of CARE oral home equipment for the remedy of extreme OSA.
About OSA in kids
Pediatric OSA happens when a toddler’s airway turns into partially or utterly blocked throughout sleep, inflicting respiratory pauses. Signs embody loud night breathing, labored respiratory throughout sleep, extreme daytime sleepiness and morning complications. Kids might also expertise cognitive and behavioral issues, akin to hyperactivity and poor college efficiency. Adenotonsillectomy is the commonest remedy for OSA in kids.
About oral equipment therapyOral equipment remedy is a non-invasive remedy for loud night breathing and OSA, involving the usage of a detachable system worn within the mouth throughout sleep. These home equipment, various in look, are favored by some sufferers for his or her ease of use and portability, as they’re smaller and extra travel-friendly in comparison with conventional CPAP machines, taking just a few weeks for most people to adapt to sleeping with them.
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