The United States Food and Drug Administration (FDA) has approved additional magnetic resonance imaging (MRI) scan conditions for use with Inspire Medical Systems Inc’s Inspire therapy for obstructive sleep apnea.
This full-body MRI approval expands the Inspire use labeling that previously allowed only head, neck, and extremity MRI scans. Most importantly, this approval is retroactive, applying to all patients with the Inspire IV neurostimulator device, introduced in 2018, already in place.
“Expanding compatible use to include full-body MRI is a significant milestone in our effort to bring Inspire to more obstructive sleep apnea patients who struggle with CPAP. Providing the full range of scan options enables us to better help all current and future patients with their imaging needs,” says Tim Herbert, president and CEO of Inspire, in a release. “Until now, concern over future access to MRI had been a barrier for some patients considering Inspire therapy. Compatibility with this important diagnostic tool will provide peace of mind for current and future Inspire patients.”
MRI scanners use powerful magnets and radiofrequency energy to create detailed images of the inside of the body. Every year, millions of MRIs are performed in the United States to evaluate cancer, neurological, musculoskeletal, and other conditions. Inspire has completed extensive testing to validate performance in the 1.5T MRI environment and demonstrate the conditions that allow scans to be performed safely.
For detailed information about Inspire MRI conditional labeling, access Inspire MRI Guidelines online.