Inspire Medical Systems has secured the CE Mark certification of full-body MRI compatibility for its Inspire IV neurostimulator device under the European Union’s Medical Device Regulation (EU MDR).
This approval extends the use of Inspire therapy beyond the previously allowed head, neck, and extremity MRI scans.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
Inspire chairman and CEO 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 United States for the past two years, and this new approval will provide the same positive benefit for patients in Europe going forward.”
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataInspire Medical Systems has conducted thorough testing to confirm that the Inspire IV neurostimulator can perform safely within a 1.5T MRI environment.
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.
The company is engaged in the development and commercialisation of minimally invasive solutions for OSA patients.
