Abstract Introduction As part of the approval to market and sell implanted medical devices, regulatory bodies mandate device manufacturers to collect data for any surgical revisions or explants required by their device. Combining this post market surveillance data with total implant counts can provide the real world rates for these procedures and help determine whether the safety data produced in a pivotal approval trial holds up in broad clinical applications. We calculated the cumulative revision and explant rates for the closed loop upper airway stimulation device produced by Inspire Medical Inc. (Golden Valley, MN USA). Methods Counts of revision and explant procedures were extracted from Inspire Medical Incorporated’s post market surveillance data. Procedures were grouped by calendar year of initial implant, and rates were calculated using the corresponding year’s total implant count. Implants prior to 2018 were excluded. Results Within 3 years of implant, cumulative revision procedures - shown as percent (implant year) - were 5.5% (2018), 3.4% (2019), 3.6% (2020), 2.6% (2021), and 2.6% (2022). Cumulative explant rates for this period were 2.4% (2018), 2.1% (2019), 2.5% (2020), 1.5% (2021), and 1.5% (2022). Within five years of implant the cumulative revision rates were 8.5% (2018), 5% (2019), and 4.8% (2020). Cumulative explant rates for this period were 4.3% (2018), 3.4% (2019), and 3.1% (2020). Conclusion Overall, the risk of surgical revision or explant of the closed loop upper airway stimulator is low. That the explant rates are lower than the revision rates suggest the patients receive a clinical benefit from the device and prefer to correct the underlying problem rather than remove the device. This analysis shows a trend of decreased events by later implant years, suggesting that improvements in the device components as well as surgical training have reduced patient risk. Support (if any) This work was funded by Inspire Medical Incorporated.
Aloia et al. (Fri,) studied this question.