Sam Brusco, Associate Editor03.21.24
LivaNova has released data from its OSPREY clinical study, Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation.
According to the company, the study had a positive outcomes and will finish enrollment earlier than anticipated—meaning there’s an over 97.5% probability the OSPREY trial will meet its primary endpoint. The trial is evaluating the company’s aura6000 hypoglossal nerve stimulator system against a no stimulation control in patients with moderate to severe obstructive sleep apnea (OSA) who failed or are unwilling to use positive airway pressure treatment.
The study’s primary endpoint to showing the apnea-hypopnea index (AHI) responder rate of subjects using device stimulation is significantly higher than those without stimulation after seven months of follow-up. Response in the OSPREY trial means at least a 50% improvement from the baseline AHI, leading to a value below 20.
After the cohort completes the seven-month follow-up visit and results are done, LivaNova plans to submit OSPREY’s clinical module to the U.S. Food and Drug Administration (FDA).
“A planned interim analysis, per the approved protocol, was conducted for the first 90 patients enrolled in OSPREY. We are now able to estimate a high chance of success for achieving the primary endpoint in this unique randomized controlled trial without further patient enrollment,” said Dr. Atul Malhotra, Professor of Medicine at University of California, San Diego and Principal Investigator for OSPREY. “While this milestone shows we are on a positive trajectory, long-term follow-up visits will continue for each patient through the primary endpoint and beyond.”
“We are pleased to have achieved this positive milestone for the OSPREY study,” added LivaNova CEO Vladimir Makatsaria, who took office last month. “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.”
Earlier this year, the company revealed it was winding down its Advanced Circulatory Support business to increase focus on its core Cardiopulmonary and Neuromodulation businesses.
According to the company, the study had a positive outcomes and will finish enrollment earlier than anticipated—meaning there’s an over 97.5% probability the OSPREY trial will meet its primary endpoint. The trial is evaluating the company’s aura6000 hypoglossal nerve stimulator system against a no stimulation control in patients with moderate to severe obstructive sleep apnea (OSA) who failed or are unwilling to use positive airway pressure treatment.
The study’s primary endpoint to showing the apnea-hypopnea index (AHI) responder rate of subjects using device stimulation is significantly higher than those without stimulation after seven months of follow-up. Response in the OSPREY trial means at least a 50% improvement from the baseline AHI, leading to a value below 20.
After the cohort completes the seven-month follow-up visit and results are done, LivaNova plans to submit OSPREY’s clinical module to the U.S. Food and Drug Administration (FDA).
“A planned interim analysis, per the approved protocol, was conducted for the first 90 patients enrolled in OSPREY. We are now able to estimate a high chance of success for achieving the primary endpoint in this unique randomized controlled trial without further patient enrollment,” said Dr. Atul Malhotra, Professor of Medicine at University of California, San Diego and Principal Investigator for OSPREY. “While this milestone shows we are on a positive trajectory, long-term follow-up visits will continue for each patient through the primary endpoint and beyond.”
“We are pleased to have achieved this positive milestone for the OSPREY study,” added LivaNova CEO Vladimir Makatsaria, who took office last month. “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.”
Earlier this year, the company revealed it was winding down its Advanced Circulatory Support business to increase focus on its core Cardiopulmonary and Neuromodulation businesses.