Two new papers on Inspire UAS for OSA-Inspire Medical Systems
A new paper, published on-line in Otolaryngology � Head and Neck Surgery, finds that withholding Inspire UAS System, from Inspire Medical Systems, causes a worsening of both objective and subjective measures of sleep disordered breathing, leading the paper's authors to directly attribute Inspire therapy for the reduction in Obstructive Sleep Apnea severity and improvement of quality of life for patients. The researchers conducted a randomized controlled therapy withdrawal study to assess the efficacy and durability of upper airway stimulation to treat OSA. Participants were randomized to either a therapy maintenance (ON) group or a therapy withdrawal (OFF) group. Short-term withdrawal effect as well as therapy durability at 18 months were assessed.
Both groups demonstrated significant improvements at 12 months compared to study baseline. In the randomized assessment, the therapy withdrawal group experienced a return of their OSA, while the therapy maintenance group remained effectively treated. At 18 months with Inspire therapy ON in all patients, both groups showed sustained improvements similar to 12 months. A second paper has been published on-line by the European Respiratory Journal, on research to define the mechanism on how Inspire therapy works to relieve systems of OSA. The research demonstrated that Inspire therapy increases the airway at multiple levels including near the back of the tongue as well as at the level of the soft palate. Data from both papers will be presented at the 75th annual scientific meeting of the American Academy of Otolaryngology. See: "Effect of upper-airway stimulation for obstructive sleep apnoea on airway dimensions." Faiza Safiruddin et al. European Resp. Journal September 3, 2014, doi: 10.1183/09031936.00059414 and "Randomized Controlled Withdrawal Study of Upper Airway Stimulation on OSA Short- and Long-term Effect" B. Tucker Woodson et al. Otolaryngol Head Neck Surg, September 9, 2014, doi: 10.1177/0194599814544445