– First and only hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication or warning language

– Next-generation, MRI-compatible device expected to launch in the first half of 2027, pending FDA supplement review

LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the aura6000™ System for the treatment of adult patients with moderate to severe Obstructive Sleep Apnea (OSA). The System utilizes proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with an apnea-hypopnea index (AHI) between 15 and 65 and who have failed, do not tolerate, or are ineligible for first-line therapies, such as positive airway pressure (PAP).

Building upon the FDA PMA approval, LivaNova is continuing to prepare its next-generation OSA device for a PMA supplement application to the FDA. This device is being designed for compatibility with magnetic resonance imaging (MRI), remote and secure configuration management capabilities, and long-lasting, rechargeable battery technology (up to 15 years).