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Inspire Medical announced that physicians presented updates from multiple clinical trials evaluating Inspire therapy for the treatment of OSA at the American Academy of Otolaryngology - Head Neck Surgery, or AAO-HNSF. Sean Evans and Dr. Kirk Withrow from the University of Alabama at Birmingham reported on a study comparing the effect of Inspire therapy on Medicare-aged patients and younger patients in a cohort of 600 patients. The study included 365 patients younger than 65 years and 235 patients who were 65 years or older. The data demonstrated that both groups experienced a statistically significant reduction in their Apnea Hypopnea Index, or AHI, following 12 months of Inspire therapy. The Medicare-aged population had a mean AHI of 7.6 events per hour, as compared to an AHI of 11.9 events per hour for the younger population. Both groups also experienced a statistically significant improvement in their quality of life. In addition, the average utilization of the Inspire therapy was 6 hours per night in the Medicare-aged population and 5.4 hours per night in the population of patients under 65 years of age. This is the first study that specifically addressed the safety and efficacy of Inspire therapy in a Medicare-aged population. The manuscript of this clinical evidence has been submitted to a leading medical journal for publication.

Inspire Medical announced the first implant of its new sensing lead in Europe. The implant was successfully completed by Joachim Maurer, University Hospital, Mannheim, Germany, who has now overseen 80 Inspire therapy cases. Maurer is an ear nose and throat, or ENT, surgeon and head of the sleep disorders center. The sensing lead monitors a patient's respiratory pattern as the implanted Inspire system delivers stimulation to the upper airway in order to prevent obstructions during sleep. The new 4340 sensing lead has a smaller profile, including a reduction in diameter of 49%, as compared to the prior design. This diminished profile improves patient comfort. The new design also incorporates several features to enhance the ease of implant and reduce surgical time for an ENT surgeon. Inspire intends to introduce the new sensing lead to other centers in Europe in the near future. Currently, the 4340 sensing lead is under review by the FDA and, pending clearance, the company expects the product to be available in the U.S. in early 2019.