0752 Preliminary Efficacy of a Novel Iterative Device and Material

Abstract

Abstract Introduction Launching a new device design or use of a new material with optimistic expectations should always be undertaken with caution and an ounce of skepticism. When this novel device and material was first described in an IRB Abstract derivative report at the AASM, it was under the umbrella of a patient and provider preference survey. In April 2020, the broader availability post FDA clearance is providing strong early indications of excellent efficacy. Methods An analysis of data from four treatment centers using this novel device and material was undertaken. Patients were to be included if they had a diagnosis of mild, moderate, or severe OSA confirmed by a physician, and an AHI score >5 and a follow up study resulting in treatment success or failure. Results would be grouped as Complete Success = AHI <5, Clinical Success = 50% reduction and <10. All patients were to be treated with the Novel ProSomnus EVO Iterative advancement device. Results 55 total consecutive patients were treated at four centers for dental sleep medicine. 37 male and 18 female patients with an average age of 53.3 ranging from 30 to 78 with pre and post data were included and treated with a ProSomnus EVO. The initial AHIs ranged from 6.0 to 116.0 with an average of AHI pretreatment of 26.4 (15 mild, 23 moderate and 17 severe). Follow up testing for this group revealed an average overall reduction in AHI of 75%, from 26.4 to 6.6. Overall, 62% resolved to below an AHI of 5 (100% of mild, 65% of moderate and 24% of severe patients). Similarly, 85% resolved to below an AHI of 10 and a 50% reduction (100% of mild, 96% of moderate and 59% of severe patients) Conclusion This novel interactive device and material combination appear, after early analysis, appear to yield significantly better results that previous data has demonstrated. The literature suggests that legacy oral appliance efficacies range from 50%-62% and other AADSM poster/abstracts have reported similar precision milled, control cure PMMA appliances in the 74% - 76% range. These results suggest a need for further investigation of exceptional efficacy for this device design and material. Support (If Any) No support was provided for this abstract