The device, which has been designed to provide new options for treating Obstructive Sleep Apnea (OSA), will expand the company’s suite of FDA-approved precision oral appliance therapy devices for the treatment of OSA
ProSomnus, a manufacturer of medical devices to treat Obstructive Sleep Apnea (OSA), has secured the US Food and Drug Administration (FDA) 510(k) approval for its ProSomnus EVO [PH] sleep and snore device.
The device joins the company’s ProSomnus EVO family of FDA-approved, patient-preferred, less invasive precision oral appliance therapy (OAT) devices for the treatment of OSA.
It is designed to meet Medicare guidelines and provides a simple, non-invasive alternative to CPAP machines, surgical procedures, and legacy oral devices.
The device leverages mechanical hinge components to accurately reposition the patient’s jaw during sleep, to increase the pharyngeal space and reduce the risk of upper airway collapse, said the company.
ProSomnus co-founder and chief executive officer Len Liptak said: “Receiving FDA clearance for the ProSomnus EVO [PH] is a significant milestone for the company and patients suffering from OSA.
“This expands our industry-leading suite of FDA-cleared precision medical devices to treat OSA, offering patients and their healthcare providers yet another alternative to CPAP, surgery and legacy oral appliances.
“Successfully addressing OSA starts with giving patients a treatment that is safe, effective, and easier to adhere to, and the EVO [PH] is one more patient-preferred Precision OAT option available to them.”
OSA is characterised by the recurring collapse of the airway during sleep, leading to the shortage of oxygen and abrupt awakenings, along with gasping or choking.
It is associated with serious comorbidities including daytime sleepiness, heart failure, stroke, hypertension, morbid obesity, and type 2 diabetes.
According to the company, each device is personalised and digitally manufactured based on the patient’s unique anatomy and the healthcare provider’s treatment plan for each patient.
It is the only Herbst-style device made from engineered, medical-grade Class VI-rated material, and is designed to be around 13% smaller than predicate devices.
The device features unique comfort bumps around key components, along with markings and visual indicators to simplify communication between the user and healthcare provider.
ProSomnus co-founder and chief technology officer Sung Kim said: “We are continuously expanding our material selection far beyond dental applications and researching and developing innovative medical grade polymers for our products.
“The improved flexibility of the ProSomnus EVO [PH] makes it even easier for patients to use, while its durability protects it from accidental drops.
“In addition to being incredibly stain-resistant, the EVO [PH] is precision milled in one piece, so it maintains its fit throughout treatment without deformation, staining or harbouring bio-burden, unlike soft liner and nylon materials.”