Inspire Medical Systems Inc. has gained European Union Medical Device Regulation (EU MDR) approval for additional magnetic resonance imaging (MRI) scan conditions used with Inspire therapy.  The approval is retroactive and applies to all patients with the Inspire IV neurostimulator device (introduced in 2018) already in place.

The full-body MRI approval expands the Inspire use labeling that previously allowed only head, neck, and extremity MRI scans.
 
“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,” Inspire Chairman/CEO Tim Herbert said. “This full-body MRI compatibility has been an important benefit for patients in the United States for the past two years, and this new approval will provide the same positive benefit for patients in Europe going forward.”
 
MRI scanners use powerful magnets and radiofrequency (RF) energy to create detailed images of the body’s internal mechanisms. Millions of MRIs are performed annually in Europe 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.

“Until now, concern over future access to MRI had been a barrier for some patients considering Inspire therapy,” said Andreas Henke, executive vice president and managing director, Europe. “Compatibility with this important diagnostic tool will provide peace of mind for current and future Inspire patients.”
 
Inspire is a medical technology company developing and commercializing innovative, minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy reportedly is the first and only U.S. Food and Drug Administration-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.