Inspire’s Sleep Apnea Therapy Gains EU Nod for Full-Body MRI Scans

Inspire Medical Systems has earned EU MDR approval for full-body MRI scan conditions with its Inspire obstructive sleep apnea (OSA) therapy.

This approval expands Inspire’s use labeling, which was previously limited to head, neck, and extremity MRI scans. The approval is also retroactive, applying to patients with the Inspire IV neurostimulator device already in place.

The MDR nod was based on extensive testing conducted by Inspire to validate performance in the 1.5T setting and show conditions that allow for safe 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,” said Tim Herbert, chairman and CEO of Inspire. “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.”

“Until now, concern over future access to MRI had been a barrier for some patients considering Inspire therapy,” added Andreas Henke, Inspire’s executive VP, and managing director Europe. “Compatibility with this important diagnostic tool will provide peace of mind for current and future Inspire patients.”