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LivaNova Announces 12-month Data from OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea, Demonstrating Strong Response and Durability of Therapy
Top-line results at 12 months of treatment show meaningful improvement over time: Overall responder rate of 65% Overall reduction in median apnea-hypopnea
About this update from Livanova Plc
[{"type":"text","content":"\nTop-line results at 12 months of treatment show meaningful improvement over time:\nOverall responder rate of 65%\nOverall reduction in median apnea-hypopnea index of 68%\nOverall reduction in median oxygen desaturation index of 68%\n\n LONDON--(BUSINESS WIRE)--\nLivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced 12-month, top-line data from its OSPREY randomized controlled trial (RCT), evaluating outcomes with the aura6000™ System for the treatment of moderate to severe obstructive sleep apnea (OSA). At 12 months of therapy, the treatment arm responder rate was 65% with responders defined as those who realized at least a 50% improvement from the baseline apnea-hypopnea index (AHI) and an AHI value below 20. The study features a differentiated neurostimulation modality called proximal hypoglossal nerve stimulation (p-HGNS), which utilizes six electrodes placed on the proximal trunk of the hypoglossal nerve, offering broad access to the muscles controlling the airway and providing customized titration.\n\nIn November 2024, the company announced that OSPREY met its primary and secondary endpoints following six months of therapy. Study patients in the treatment arm of OSPREY have since shown continued improvement. When comparing baseline median values to six and 12 months of therapy (assessed at the seven- and 13-month follow-up visits, respectively), OSPREY subjects showed significant reductions in AHI and oxygen desaturation index (ODI) over time:\n\n\nAHI reduced by 68% when the median at baseline of 34.3 is compared to the median of 11.0 at 12 months (versus the median of 11.6 at six months).\n\n\nODI reduced by 68% when the median at baseline of 34.9 is compared to the median of 11.1 at 12 months (versus the median of 12.8 at six months).\n\n\nFurther, after 12 months of treatment, OSPREY subjects in the device stimulation group experienced clinically meaningful improvements in the Epworth Sleepiness Scale (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ). ESS and FOSQ as compared to baseline are secondary outcome measures within the study. ESS is a patient questionnaire that assesses how likely the patient is to fall asleep during the day and FOSQ is a patient questionnaire that assesses the effects of fatigue on daily activities.\n\n\"OSPREY is the first major multi-cente...