LivaNova PLC announced that its OSPREY randomized controlled trial for the aura6000™ System met its primary safety and efficacy endpoints. The aura6000 System is an implantable hypoglossal neurostimulator designed to treat adult patients with moderate to severe obstructive sleep apnea (OSA). The study achieved statistical significance in its primary endpoint responder rates between the treatment and sham arms.
Top-line results at six months showed a median apnea-hypopnea index (AHI) reduction of 66.2% and a median oxygen desaturation index (ODI) reduction of 63.3% compared to baseline. A responder was defined as having at least a 50% improvement from baseline AHI, leading to an AHI value below 20. No serious adverse device-related or procedure-related events were reported during the primary endpoint visits.
LivaNova plans to submit the OSPREY clinical data to the U.S. Food and Drug Administration (FDA) as part of its premarket approval submission for the aura6000 System. This successful trial reinforces the potential of targeted hypoglossal nerve stimulation as an alternative for OSA patients, opening a path to a new market.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.