LivaNova reports positive predictive outcome for OSPREY trial for OSA

LivaNova announced its OSPREY clinical study, Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation, has achieved a positive predictive outcome and will conclude enrollment earlier than anticipated. This means there is a greater than 97.5% probability that the OSPREY trial will successfully meet its primary endpoint. OSPREY is a prospective, multi-center, randomized controlled open-label trial demonstrating the safety and effectiveness of the aura6000 Hypoglossal Nerve Stimulator System versus a no stimulation control in subjects with moderate to severe obstructive sleep apnea OSA who have failed or are unwilling to use positive airway pressure treatment. LivaNova notified the U.S. Food and Drug Administration FDA and its partner trial sites of this significant milestone for the OSPREY study.”…The OSPREY study’s primary efficacy endpoint is the demonstration that the apnea-hypopnea index or AHI, responder rate of subjects with device stimulation activated is statistically significantly higher than the rate of subjects without stimulation after seven months of follow-up. For OSPREY, response is defined as at least a 50% improvement from the baseline AHI, leading to an AHI value below 20. After the full cohort completes the seven-month follow-up visit and the results are compiled, LivaNova will submit OSPREY’s final clinical module to the FDA. “We are pleased to have achieved this positive milestone for the OSPREY study,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova. “In accordance with the study protocol, once the last patient implanted completes their final follow-up visit, we will conduct the final analysis for the study. Until then, we will continue to actively work with the clinical sites to manage the study patients.”