LivaNova Secures FDA Approval for Clinical Study to Assess the aura6000 System for Obstructive Sleep Apnea Treatment
On June 15, 2021, LivaNova PLC received approval from the US Food and Drug Administration (FDA) to continue with its investigational device exemption (IDE) clinical study, “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation (OSPREY).” The OSPREY study will attempt to demonstrate the safety and effectiveness of the aura6000® System, the LivaNova implantable hypoglossal neurostimulator for treating adult patients with moderate to severe obstructive sleep apnea (OSA).
The aura6000 System is an innovative alternat...
