LivaNova plans 2027 launch of aura6000 sleep apnoea therapy after FDA approval

The US FDA granted premarket approval for LivaNova's aura6000 system, and the company is preparing for a commercial launch targeted for H1 2027 pending a PMA supplement review. Regulatory support was based on positive results from the 150-patient OSPREY trial, which reported substantial reductions in AHI and oxygen desaturation index at six months.

LivaNova's aura6000 system has received premarket approval from the US Food and Drug Administration, and the company is preparing for a commercial launch targeted for 2027. Aura6000 uses proximal hypoglossal nerve stimulation delivered by a pulse generator implanted near the clavicle to synchronise with breathing and reduce airway collapse during sleep. The system is intended for moderate- to severe obstructive sleep apnoea patients with an apnoea-hypopnea index between 15 and 65 who have not succeeded with or were ineligible for CPAP. The PMA was supported by data from the 150-patient OSPREY trial, which met its primary safety and efficacy endpoints. Key facts: - The FDA granted premarket approval (PMA) for the aura6000 system. - The OSPREY trial was a 150-patient, sham-controlled study that reported a median AHI reduction of 66.2% and a median oxygen desaturation index reduction of 63.3% at six months versus baseline. - Additional OSPREY data released in May 2025 reported a treatment-arm responder rate of 65% based on AHI improvements. - Aura6000 uses proximal hypoglossal nerve stimulation (p-HGNS) via an implanted pulse generator near the clavicle to move the tongue forward and reduce airway collapse; it is intended for patients with AHI between 15 and 65 who have not used or cannot use CPAP. - LivaNova is developing a next-generation device designed for MRI compatibility and enhanced remote and secure configuration management, and it is seeking a PMA supplement for that system. - The American Lung Association reports that roughly 30 million people in the US have obstructive sleep apnoea. Summary: The FDA PMA represents a regulatory milestone for LivaNova's aura6000 and reflects the trial data reported from OSPREY. The company is progressing toward commercialisation and is pursuing a PMA supplement for a next-generation, MRI-compatible system with enhanced remote configuration, with an anticipated launch in H1 2027 pending review.