공고 • Apr 21
LivaNova PLC Publishes 12-Month Results From OSPREY Clinical Study For Obstructive Sleep Apnea
LivaNova PLC announced that the journal Annals of Internal Medicine has published an article chronicling the full 12-month data set for the Company’s OSPREY randomized controlled trial (RCT). The researchers evaluated the safety and efficacy of proximal hypoglossal nerve stimulation (pHGNS), a differentiated neurostimulation modality, when delivered by LivaNova’s aura6000 System for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). Overall, the authors concluded that pHGNS for OSA yielded clinically significant improvements versus the control at month (M) 7 with sustained improvements through M13 of OSPREY, corresponding with six and 12 months of therapy, respectively, providing unique RCT evidence for clinically relevant improvements in apnea-hypopnea index (AHI), sleep quality, and patient-reported outcomes (PROs). In “Proximal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea, the OSPREY Study: A Randomized Controlled Trial,” the study explored pHGNS as a potential alternative for adult patients with OSA who are intolerant of positive airway pressure (PAP) therapy. pHGNS utilizes six electrodes placed on the proximal trunk of the hypoglossal nerve, offering broad access to the muscles controlling the airway and a wider set of titration options. A total of 104 adults participated in OSPREY, with more diverse demographic profiles and greater OSA severity than in other pivotal HGNS trials, including higher body mass index (BMI) and no exclusion for complete concentric collapse (CCC). The no stimulation-controlled 2:1 randomized study, with therapy initiated at M1 (treatment) and M7 (control), was rigorously designed. Study outcome measures included the proportion of patients achieving at least a 50% improvement from the baseline AHI and an AHI of less than 20 e/hr. The median AHI in the pHGNS treatment group was 34.3 e/hr at baseline and 11.6 e/hr at M7; the difference in median (95% confidence interval) AHI between the treatment and control groups at M7 was -18.9 (-27.0, -10.6) e/hr. By M13, outcomes improved in both groups; median AHI in the pHGNS treatment group was 11.0 e/hr with treatment and 20.9 e/hr in the control group (now active). CGI-I response rate in the treatment group exceeded the control group at M7 (56% vs 9%) and increased to 59% at M13. PROs included ESS scores demonstrating improvement in treatment group at M7 (median score 10.0 to 6.0) beyond the minimal clinically importance difference (MCID) of 2, but not in control group (median score 9.0 to 9.0). By M13, both groups improved on therapy from baseline. For the FOSQ, there was an improvement from baseline to M7 in the treatment group (median score 15.8 to 17.8) meeting the MCID of 2, but not in the control group (median score 16.0 to 16.3). By M13, both groups improved on therapy from baseline to median scores of 18.5 (treatment) and 18.3 (control, now active). Arousals from sleep significantly declined with pHGNS stimulation therapy. The treatment group at baseline had an arousal index of about 55/hr despite having a sleep efficiency of =85%, and at M13 arousals declined to 29/hr. Of note, respiratory arousals were essentially resolved while some non-respiratory arousals persisted. No serious procedure-related adverse events were reported. Most treatment-emergent adverse events (TEAEs) were mild or moderate in severity, and the most common events were headache, implant site pain, and difficulty swallowing. OSPREY baseline values of OSA severity and BMI were representative of the general OSA population. OSPREY did not exclude patients with CCC. Based on a recently presented predictive algorithm, it was determined that the OSPREY study enrolled patients at increased risk of CCC at a ratio aligned with the general OSA population seen in clinical practice. Response rates and AHI reductions with 12 months of pHGNS therapy for patients in OSPREY with predicted risk for CCC were consistent with the results for the full study population, demonstrating the robustness of the therapeutic response. As reported in March, LivaNova received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the aura6000 System, an implantable proximal hypoglossal neurostimulator, after meeting OSPREY’s primary safety and efficacy endpoints following six months of treatment. Building upon the FDA PMA approval, LivaNova is preparing its next-generation OSA device for a PMA supplement application to the FDA. This device is being designed for compatibility with magnetic resonance imaging (MRI), remote and secure configuration management capabilities, and long-lasting, rechargeable battery technology (up to 15 years). Pending a successful conclusion of the FDA’s review, the Company anticipates commercializing its OSA product independently in 2027. OSPREY, a prospective, multi-center, randomized, controlled, open-label clinical trial, evaluated the safety and efficacy of the aura6000 System compared to a no-stimulation control in adult subjects with moderate to severe obstructive sleep apnea (OSA) who failed, do not tolerate, or are ineligible for treatment with standard-of-care therapies, including positive airway pressure (PAP). Data from the OSPREY trial supported U.S. Food and Drug Administration (FDA) approval of the aura6000 System (PMA P250013).
