Inspire Medical Systems has secured the CE mark certification for full-body magnetic resonance imaging (MRI) compatibility for its Inspire IV neurostimulator device under the European Union’s (EU) medical device regulation (MDR).
This approval extends the use of Inspire therapy beyond the previously allowed head, neck, and extremity MRI scans. The CE mark approval retroactively applies to all patients implanted with the Inspire IV neurostimulator since 2018. This advancement ensures that these patients can now safely undergo full-body MRI scans, the recent press release details.
Inspire chairman and chief executive officer Tim Herbert said: “Expanding compatible use to include full-body MRI is a significant milestone in our effort to bring Inspire to more obstructive sleep apnoea (OSA) patients who struggle with CPAP [continuous positive airway pressure]. Providing the full range of scan options enables us to better help all current and future patients with their imaging needs.
“This full-body MRI compatibility has been an important benefit for patients in the USA for the past two years, and this new approval will provide the same positive benefit for patients in Europe going forward.”
Inspire Europe managing director and executive vice-president Andreas Henke said: “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.”
The therapy is said to be the first and only US Food and Drug Administration (FDA)-approved neurostimulation technology designed to provide a safe treatment for moderate to severe OSA.
