LivaNova Gets FDA OK for Study to Evaluate aura6000 System for Obstructive Sleep Apnea

  LivaNova PLC   (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced it has received approval from the U.S. Food and Drug Administration (FDA)   to proceed with its investigational device exemption (IDE) clinical study, “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation (OSPREY).” The OSPREY study will seek to demonstrate the safety and effectiveness of the aura6000^® System, the LivaNova implantable hypoglossal neurostimulator intended to treat adult patients with moderate to severe obstructive sleep apnea (OSA).

An innovative alternative to the traditional continuous positive airway pressure (CPAP) machine, the aura6000 System generates stimulation through a programmable, rechargeable and implantable pulse generator (IPG). The IPG is implanted in a subcutaneous pocket near the clavicle of the patient via an outpatient surgery. Mild stimulation pulses from the IPG are delivered via a lead to the hypoglossal nerve to stimulate the tongue during sleep and help keep the patient’s airway open. With the aura6000, there are no masks, hoses or mouthpieces connected to the patient during sleep.

https://www.biospace.com/article/releases/livanova-receives-fda-approval-for-clinical-study-to-evaluate-the-aura6000-system-to-treat-obstructive-sleep-apnea/