LivaNova receives FDA premarket approval for CPAP alternative

LONDON – LivaNova has announced that the U.S. Food & Drug Administration (FDA) has granted premarket approval (PMA) for the aura6000 System for the treatment of adult patients with moderate to severe obstructive sleep apnea (OSA). The system uses 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). “FDA approval of the aura6000 marks a transformative moment for LivaNova and represents a major step forward for patients struggling with inadequately treated OSA,” said Ahmet Tezel, Ph.D., chief innovation officer for LivaNova. “Our p-HGNS therapy underwent a rigorous evaluation for safety and efficacy in the OSPREY randomized controlled trial and delivered clinically significant responses and sustained improvements over time. Now, with FDA approval secured, we are advancing the device toward an even more sophisticated, next-generation system for patients and, ultimately, commercialization.” Building on FDA PMA approval, LivaNova is continuing to prepare its next-generation OSA device for a PMA supplement application to the FDA. The FDA PMA approval is supported by data from OSPREY, LivaNova’s prospective, multi-center, randomized controlled trial. As previously announced in November 2024, OSPREY met its primary endpoints following six months of p-HGNS therapy, with study data demonstrating clinically significant reductions in AHI and oxygen desaturation index (ODI), in addition to several patient-reported outcomes relevant to sleep disturbance.