Home / Health / FDA Approves LivaNova's Aura6000 for Sleep Apnea
FDA Approves LivaNova's Aura6000 for Sleep Apnea
20 Mar
Summary
- FDA approved LivaNova's aura6000 for obstructive sleep apnea.
- The device uses hypoglossal nerve stimulation to prevent airway collapse.
- A next-generation, MRI-compatible device is planned for 2027.
LivaNova has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its aura6000 system, an innovative treatment for moderate to severe obstructive sleep apnea (OSA). This neuromodulation device works by stimulating the hypoglossal nerve to prevent airway collapse during sleep, offering a new option for patients who do not tolerate or benefit from traditional therapies like CPAP.
The FDA's decision was underpinned by data from the OSPREY trial, which demonstrated substantial reductions in the apnea-hypopnea index (AHI) and oxygen desaturation index after six months of therapy. These positive results have paved the way for LivaNova to advance its next-generation OSA device, which is being engineered for MRI compatibility and improved remote management capabilities.
With the PMA in hand, LivaNova is now preparing for the anticipated launch of the aura6000 system in the first half of 2027. This approval marks a significant milestone, addressing the needs of millions affected by OSA and highlighting the growing potential of neuromodulation in treating sleep disorders.
