LivaNova (Nasdaq:LIVN) today announced that its OSPREY trial of nerve stimulation for treating sleep apnea met its primary endpoints.
OSPREY evaluates targeted hypoglossal nerve stimulation in the treatment of obstructive sleep apnea. With its safety endpoints, the trial achieved statistical significance in its primary endpoint responder rates between the treatment arm and the sham arm for the implantable LivaNova aura6000 nerve stimulation system.
The study looked at apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) reductions as secondary endpoints. It compared median values from baseline to six months with therapy and found that aura6000 subjects experienced significant reductions in these endpoints.
AHI was reduced by 66.2% when comparing the median at baseline of 34.3 to the median of 11.6 at six months. ODI reduced by 63.3% when comparing the median at baseline of 34.9 to the median of 12.8 at six months. Investigators reported no serious adverse device-related or procedure-related events through the primary endpoint visits.
Once LivaNova completes an analysis of six-month results, the company plans to submit OSPREY data for FDA premarket approval. Beyond primary endpoints, LivaNova plans for OSPREY to continue collecting long-term data. It expects data to come in the first half of 2025 once all subjects complete 12 months with therapy.
“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,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova. “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.”
