LivaNova has announced positive results from its OSPREY randomised controlled trial (RCT) of the LivaNova aura6000 System for treating obstructive sleep apnoea (OSA).
LivaNova aura6000 is an implantable hypoglossal neurostimulator for adults with moderate to severe OSA. It generates stimulation via a rechargeable, programmable, implantable pulse generator (IPG).
The device is designed as an alternative to the traditional continuous positive airway pressure (CPAP) machines.
The OSPREY trial met its primary endpoints, showing statistically significant responder rates between the treatment and sham arms for the LivaNova aura6000 System. Safety endpoints were also achieved in the trial.
The London-based medical technology company previously received approval from the US Food and Drug Administration (FDA) to initiate the OSPREY study.
In March this year, LivaNova announced a positive predictive outcome of trial success in the OSPREY clinical study.
Key secondary endpoints in the study included reductions in the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI).
At six months, subjects in the device stimulation group experienced significant improvements.
Specifically, AHI decreased by 66.2%, with the baseline median of 34.3 reducing to 11.6. ODI, on the other hand, decreased by 63.3%, with the baseline median of 34.9 dropping to 12.8 at six months.
No serious device-related or procedure-related events were reported in the OSPREY trial during the primary endpoint visits.
LivaNova CEO Vladimir Makatsaria said: “The study results reinforce our belief that targeted hypoglossal nerve stimulation provides a compelling alternative for patients with obstructive sleep apnoea.
“The significant reductions in AHI and ODI achieved after only six months of therapy gives us strong evidence of this technology’s potential at 12 months and beyond.”
Once the six-month analysis is completed, Nasdaq-listed LivaNova plans to submit the OSPREY clinical data to the FDA as part of its premarket approval submission for the aura6000 System.
Beyond meeting the primary and safety endpoints, the OSPREY trial will continue to collect long-term data.
After all subjects complete 12 months of therapy, with an assessment at the 13-month follow-up visit, the medical technology firm expects to have the data available in the first half of 2025.
