LivaNova PLC announced on Mar. 20 that its aura6000 System for treating adult patients with moderate to severe Obstructive Sleep Apnea (OSA) has received premarket approval from the United States Food and Drug Administration.
The approval is significant for patients who have not responded to, cannot tolerate, or are ineligible for first-line therapies such as positive airway pressure. The aura6000 System uses proximal hypoglossal nerve stimulation (p-HGNS), a neurostimulation method designed to reduce airway obstruction during sleep.
Ahmet Tezel, Ph.D., Chief Innovation Officer for LivaNova, said, “FDA approval of the aura6000 marks a transformative moment for LivaNova and represents a major step forward for patients struggling with inadequately treated OSA. Our p-HGNS therapy underwent a rigorous evaluation for safety and efficacy in the OSPREY randomised controlled trial and delivered clinically significant responses and sustained improvements over time. Now, with FDA approval secured, we are advancing the device toward an even more sophisticated, next-generation system for patients and, ultimately, commercialisation.”
The FDA’s decision was based on data from OSPREY, LivaNova’s multi-centre randomized controlled trial. According to previously released results from November 2024 and May 2025, the study met its primary endpoints after six months of therapy. Patients experienced reductions in apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), along with improvements in patient-reported outcomes related to sleep disturbance. At twelve months of therapy, 65% of patients in the treatment group achieved at least a 50% improvement from baseline AHI and an AHI value below 20.
The OSPREY study included participants representative of the general OSA population and did not exclude those with complete concentric collapse (CCC). Outcomes showed consistent response rates among these higher-risk patients as well. Lucile Blaise, LivaNova’s Global Head of Commercialization for OSA, said, “FDA approval of the aura6000 System validates our innovative solution that will soon provide a much‑needed alternative for OSA patients who are unsuccessful with PAP and are seeking effective therapy, regardless of complete concentric collapse.”
LivaNova is preparing to submit its next-generation device—designed to be MRI-compatible with remote configuration management capabilities and long-lasting rechargeable battery technology—for further regulatory review next year.
