LivaNova aura6000 receives FDA PMA for sleep apnea — proximal hypoglossal nerve stimulation approved March 2026, 2027 launch planned
Summary
LivaNova announced FDA Premarket Approval (PMA) for the aura6000 system — their proximal hypoglossal nerve stimulation (p-HGNS) device for moderate to severe obstructive sleep apnea (OSA). The aura6000 delivers synchronized electrical pulses to the trunk of the hypoglossal nerve via a pulse generator implanted under the skin near the clavicle, preventing airway collapse during sleep. The FDA approval was based on the OSPREY randomized controlled trial, which demonstrated clinically significant and sustained improvements in OSA severity over time. Approximately 30 million US individuals have OSA. LivaNova is targeting a 2027 commercial launch and is simultaneously developing a next-generation MRI-compatible, rechargeable (up to 15 years) device for a PMA supplement submission.
Why it matters
LivaNova adding FDA-approved hypoglossal nerve stimulation for sleep apnea to their portfolio alongside VNS for epilepsy and depression creates the most diverse neurostimulation pipeline of any public neurotech company. The aura6000 competes directly with Inspire Medical's hypoglossal nerve stimulator — but LivaNova's established hospital relationships from VNS provide a distribution head start. The 30M US OSA patient population with ~50% CPAP non-adherence makes this one of the largest addressable markets in neuromodulation.
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