LivaNova PLC (NASDAQ: LIVN) received U.S. Food and Drug Administration premarket approval for its aura6000 System to treat adults with moderate to severe obstructive sleep apnea.

The device uses proximal hypoglossal nerve stimulation to treat patients with an apnea-hypopnea index between 15 and 65 who have failed or cannot tolerate positive airway pressure therapy. The approval makes it the first hypoglossal nerve stimulation therapy approved without complete concentric collapse contraindication or warning language.

LivaNova plans to launch a next-generation version in the first half of 2027, pending FDA supplement review. The updated device will be MRI-compatible and feature a rechargeable battery lasting up to 15 years.

The approval was based on data from the OSPREY randomized controlled trial. At six months, the therapy met primary endpoints with reductions in apnea-hypopnea index and oxygen desaturation index. At 12 months, 65% of patients in the treatment arm achieved responder status, defined as at least 50% improvement from baseline apnea-hypopnea index and a value below 20.

The treatment group showed a median apnea-hypopnea index reduction from 34.3 events per hour at baseline to 11.6 events per hour at seven months. The oxygen desaturation index decreased from 35 events per hour at baseline to 13 events per hour at seven months.

The OSPREY study enrolled patients representative of the general obstructive sleep apnea population and did not exclude those with complete concentric collapse. Response rates for patients at predicted risk for complete concentric collapse were consistent with the full study population.

The aura6000 System uses six electrodes placed on the proximal trunk of the hypoglossal nerve to control airway muscles and reduce obstruction during sleep.