Summary: LivaNova announced positive results from its OSPREY clinical trial, showing that its investigational aura6000 hypoglossal nerve stimulator significantly reduces the severity of obstructive sleep apnea (OSA) after six months of therapy. The study met its primary safety and efficacy endpoints, with a 66% reduction in apnea-hypopnea index (AHI) and a 63% decrease in oxygen desaturation index (ODI). LivaNova plans to submit these results to the FDA for premarket approval.
Key Takeaways:
- Significant Reductions in Sleep Apnea Severity: The aura6000 neurostimulator showed a 66% decrease in AHI and a 63% reduction in ODI after six months of use, highlighting its potential as an effective treatment for moderate to severe OSA.
- OSPREY Trial Meets Safety and Efficacy Endpoints: The trial demonstrated statistically significant improvements in OSA patients using the neurostimulator compared to a sham group, with no serious device-related adverse events reported.
- FDA Approval Submission Planned: LivaNova plans to use the trial results to support its premarket approval submission to the FDA.
LivaNova announced that its OSPREY clinical trial of the aura6000 hypoglossal nerve stimulator for treating obstructive sleep apnea (OSA) has met its primary safety and efficacy endpoints, demonstrating significant reductions in sleep apnea severity and oxygen desaturation after six months of therapy
Together with its safety endpoints, the trial achieved statistical significance of its primary endpoint responder rates between the treatment arm and the sham arm for the LivaNova aura6000 System. The aura6000 is an implantable hypoglossal neurostimulator intended to treat adult patients with moderate to severe OSA.
In the OSPREY study, apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) reductions are analyzed as part of the study’s secondary endpoints. Comparing median values from baseline to six months with therapy (assessed at the seven-month follow-up visit), OSPREY subjects in the device stimulation group experienced significant reductions in these endpoints as follows:
- AHI reduced by 66.2% when the median at baseline of 34.3 is compared to the median of 11.6 at six months.
- ODI reduced by 63.3% when the median at baseline of 34.9 is compared to the median of 12.8 at six months.
Once the six-month results analysis is completed, LivaNova will submit the OSPREY clinical data to the US Food and Drug Administration (FDA) as part of its premarket approval submission for the aura6000 System.
“The study results reinforce our belief that targeted hypoglossal nerve stimulation provides a compelling alternative for patients with obstructive sleep apnea. The significant reductions in AHI and ODI achieved after only six months of therapy gives us strong evidence of this technology’s potential at 12 months and beyond,” says Vladimir Makatsaria, chief executive officer of LivaNova, in a release. “I would like to thank the patients and physicians who have participated in OSPREY to date. We look forward to evaluating the full results as patients complete 12 months of therapy.”
Collecting Long-Term Data
Beyond the primary endpoints, the OSPREY trial will continue to collect long-term data. After all subjects have completed 12 months of therapy (assessed at the 13-month follow-up visit), LivaNova expects the data to be available in the first half of 2025.
“In addition to meeting the primary safety and efficacy outcomes, the reductions in AHI and ODI after only six months of therapy demonstrate a significant clinical impact for the patients,” says Atul Malhotra, MD, lead investigator for the study, who is also a professor of medicine at University of California San Diego School of Medicine and sleep medicine specialist at University of California San Diego Health.
There were no serious adverse device-related or procedure-related events reported in OSPREY throughout the primary endpoint visits.
Photo caption: aura6000
File photo/LivaNova
Leave a Reply