Medical technology company LivaNova has reported positive predictive outcomes from its OSPREY clinical study of the aura6000 hypoglossal nerve stimulator system for treating obstructive sleep apnoea (OSA).
Based on the latest data, the company announced the early conclusion of subject enrolment in the trial.
The OSPREY study intended to treat obstructive sleep apnea by targeted hypoglossal nerve stimulation.
The prospective, multicentre, randomised, controlled, open-label trial evaluated the safety and effectiveness of the aura6000 system versus a no stimulation control in moderate to severe OSA patients.
It enrolled patients with OSA who were unable or not willing to use positive airway pressure treatment.
Demonstrating a higher apnoea-hypopnea index (AHI) responder rate in subjects with device stimulation activated compared to subjects without stimulation after seven months of follow-up, is the trial’s primary efficacy endpoint.
Defined as a 50% improvement from baseline AHI and resulting in an AHI value below 20, the response rate is a critical measure for the study.
A planned interim analysis data indicated a greater than 97.5% chance of success in achieving the study's primary goal.
LivaNova has informed the US Food and Drug Administration (FDA) and its partner study centres about this significant achievement.
Following the completion of the seven-month follow-up for the full cohort, the company plans to submit the final clinical module of the OSPREY study to the FDA.
The study also evaluates the safety of the aura6000 system and its impact on patient quality of life, with measures such as daytime sleepiness being assessed.
LivaNova CEO Vladimir Makatsaria said: “We are pleased to have achieved this positive milestone for the OSPREY study.
“In accordance with the study protocol, once the last patient implanted completes their final follow-up visit, we will conduct the final analysis for the study. Until then, we will continue to actively work with the clinical sites to manage the study patients.”
Last year, the FDA granted 510(k) clearance to LivaNova’s Essenz heart-lung machine for use in cardiopulmonary bypass procedures.
