LivaNova receives FDA PMA approval for aura6000 hypoglossal nerve stimulation for moderate-to-severe sleep apnea

LivaNova/aura6000 hypoglossal nerve stimulation

LivaNova received FDA premarket approval (PMA) for the aura6000 System for treating moderate-to-severe obstructive sleep apnea. The OSPREY randomized controlled trial showed 65% of patients achieved ≥50% reduction in the apnea-hypopnea index with on-therapy AHI less than 20. The device is the first hypoglossal nerve stimulation therapy approved without a complete concentric collapse contraindication.

• OSPREY trial: 65% responders at 12 months; responders defined by ≥50% AHI reduction and on-therapy AHI <20.
• Approved for adults with moderate-to-severe OSA (AHI 15–65) who failed or cannot tolerate PAP therapy.
• Proximal hypoglossal nerve stimulation avoids complete concentric collapse requirement, broadening candidacy.
• MRI-compatible next-generation device expected H1 2027.