> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# LivaNova PMA OK’d for Sleep Apnea
- URL: https://www.fdaweb.com/livanova-pma-okd-for-sleep-apnea/
- Published: 2026-03-19T12:00:00.000Z
- Updated: 2026-09-14T13:35:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160851

FDA approved a LivaNova PMA for its aura6000 System, a novel implantable device designed to treat adults with moderate to severe obstructive sleep apnea. The device uses proximal hypoglossal nerve stimulation, a neurostimulation approach that activates muscles controlling the airway to prevent obstruction during sleep, according to the company.

LivaNova says it is the first and only hypoglossal nerve stimulation therapy approved in the U.S. without a contraindication or warning related to complete concentric collapse, a condition that has historically limited eligibility for similar devices. It also eliminates the need for pre-implantation drug-induced sleep endoscopy in patient selection.

Data supporting the approval came from the multi-center, randomized controlled OSPREY study, which evaluated the therapy in patients with an apnea-hypopnea index (AHI) between 15 and 65\. At 12 months, 65% of treated patients met the study’s responder criteria, defined as at least a 50% reduction in AHI and a score below 20, the company says. Patients receiving the therapy also showed marked improvements in oxygen desaturation levels and other sleep-related outcomes.

Median AHI in the treatment group dropped from 34.3 events per hour at baseline to 11.6 at seven months, with sustained benefits observed through 13 months, LivaNova says. The therapy also demonstrated consistent efficacy in patients at risk for complete concentric collapse, aligning with outcomes seen in the broader study population.