LivaNova PLC announced that the US Food and Drug Administration granted premarket approval for the aura6000 System, a hypoglossal nerve stimulation therapy for adult patients with moderate to severe obstructive sleep apnea who have failed, do not tolerate, or are ineligible for first-line therapies such as positive airway pressure, according to a press release from the company. The system is indicated for patients with an apnea-hypopnea index between 15 and 65 and is the first hypoglossal nerve stimulation device approved in the US without a contraindication or warning related to complete concentric collapse.
The aura6000 System uses proximal hypoglossal nerve stimulation, delivering therapy through six electrodes placed on the proximal trunk of the hypoglossal nerve to access airway-controlling muscles and provide customizable titration options.
The approval was supported by data from the OSPREY trial, a prospective, multicenter, randomized controlled trial evaluating proximal hypoglossal nerve stimulation. At 12 months, 65% of patients in the treatment group met responder criteria, defined as at least a 50% reduction in apnea-hypopnea index and a value below 20 events per hour. Median apnea-hypopnea index decreased from 34.3 events per hour at baseline to 11.6 events per hour at 7 months, with sustained improvement to 11.0 events per hour at 13 months. The oxygen desaturation index also improved, with 69% of treated patients achieving at least a 25% reduction compared with 38% in the control group at 7 months.
The study population included patients with predicted risk of complete concentric collapse, and treatment responses in this subgroup were consistent with those observed in the overall cohort. The system does not require drug-induced sleep endoscopy prior to implantation.
LivaNova reported ongoing development of a next-generation device designed to include magnetic resonance imaging compatibility, remote configuration capabilities, and a rechargeable battery with an anticipated lifespan of up to 15 years. The company stated the device is anticipated for release in the first half of 2027, subject to US Food and Drug Administration supplement review.
Source: LivaNova PLC
