LivaNova has announced that the first patient has been implanted with its aura6000 System for the treatment of obstructive sleep apnea (OSA) in a clinical trial that seeks to demonstrate the effectiveness and safety of the system.
The LivaNova aura6000 System, which obtained CE mark in 2012, is an implantable hypoglossal neurostimulator.
The investigational device exemption (IDE) Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation (OSPREY) study will be carried out at roughly 20 study centres in the US.
It will recruit a maximum of 150 adult patients who experience moderate to severe OSA.
LivaNova CEO Damien McDonald said: “Approximately one billion people worldwide live with OSA, but most are undiagnosed and untreated, which can seriously impact their health, increasing the rates of death, stroke, hypertension, motor vehicle accidents, heart failure, diabetes, depression and daytime sleepiness.
“The OSPREY study will be the first randomised controlled trial (RCT) to confirm efficacy of hypoglossal nerve stimulation and now, with the first OSPREY patient implanted, we are another step closer to successfully bringing the innovative aura6000 System to market.”
The first OSPREY patient was implanted at BayCare’s Morton Plant Hospital in Florida.
Designed to maintain the tongue’s muscle tone and upper airway, the aura6000 System features a rechargeable, programmable and implantable pulse generator (IPG) implanted in a subcutaneous pocket near the clavicle of the patient during outpatient surgery.
Mild stimulation generated by the IPG is delivered to the hypoglossal nerve through a lead.
This stimulates the tongue of the patient while sleeping and keeps the airway open.
The aura6000 System serves as an alternative to the traditional continuous positive airway pressure (CPAP) machine. Patients will be able to sleep without being connected to masks, hoses, facemasks or mouthpieces.