0639 Evaluation of a Next-Generation Unilateral Hypoglossal Nerve Stimulation with Respiratory Sensing Platform: Data from the Limited Market Release

Abstract Introduction The unilateral hypoglossal nerve stimulation with respiratory sensing (UHNS-RS) is an established therapy with sustained improvements in apnea severity, symptoms, and quality of life. Inspire V, the newest generation of this system, brings respiratory sensing into the implantable pulse generator, removing the separate sensing lead and making implantation simpler while keeping the core therapy the same. Early data on performance is limited. Here we describe outcomes from the first 41patients implanted during the limited market release (LMR) from May - October of 2025. Methods This is a retrospective review of 41 patients implanted during the LMR. For this early analysis, we focused on outcomes available across sites, including device-recorded nightly therapy use and whether post-therapy polysomnography (PSG) provided AHI values using established hypopnea scoring rules. Pre-therapy AHI was recorded when provided in the site documentation. Results A total of 41 patients were included. Mean nightly therapy use over the 30 days preceding in-laboratory PSG titration was 6.21 ± 2.02 hours/night (median 6.85; range 1.73–9.77). Baseline AHI was 34 ± 13.68 events/hour (median 48; range 16–66), consistent with moderate to severe obstructive sleep apnea. Forty of 41 patients (97.6%) self-reported experiencing benefit from therapy. All patients completed post-therapy PSG titration. Post-treatment AHI was available for 18 studies scored using the AASM ≥3% hypopnea rule (mean 5.25 ± 5.56 events/hour; median 3.75; range 0–13) and for 34 studies scored using the CMS ≥4% rule (mean 5.33 ± 4.62 events/hour; median 3.5; range 0–14.5); both demonstrated significant improvement from baseline (p < 0.05). Conclusion In this early limited market release group, the next-generation UHNS-RS platform showed strong early use and good completion of follow-up sleep studies. Data collection is continuing and will be presented. Support (if any) This study was funded by Inspire Medical Systems.