Nyxoah SA, makers of a European Union CE-validated neurostimulator for obstructive sleep apnea that is working on getting US Food and Drug Administration (FDA) approval, has received FDA approval for the magnetic resonance imaging (MRI) conditional labeling for the Genio neurostimulation-based OSA therapy, currently being evaluated in the DREAM pivotal IDE study.
This revised labeling ensures that patients who receive the Genio system and those already implanted can now undergo full-body 1.5T and 3T MRI diagnostic scans within approved parameters, and access the benefits of Genio bilateral stimulation therapy.
The DREAM (Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea) study is an Investigational Device Exemption (IDE) trial designed to support the marketing authorization of the Genio system in the United States. This is a multicenter study being conducted worldwide including sites in the United States, Germany, Belgium, and Australia.
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Olivier Taelman, CEO of Nyxoah, says in a release, “The approval by the Food and Drug Administration (FDA), received only a week after similar CE mark approval in Europe, confirms again the unique and unparalleled design of our technology. With the prevalence of MRI scans in the United States being one of the highest in the world, we are delighted that Nyxoah will be able to fulfill the currently unmet need for full-body 1.5T and 3T MR conditional labeling. Such an extensive labeling is unique to Nyxoah in the field of neurostimulation-based OSA therapies. Currently other therapies cannot fully address this need due to limitations to 1.5T MRI scans and body areas exclusion. As a company, Nyxoah always puts the patient first and seeks to ensure minimal disruption of their daily life and optimal quality of life.”
rincipal Investigator for the DREAM pivotal IDE study, B. Tucker Woodson, MD, says in a release, I’m really pleased with the FDA approval for full-body 1.5T and 3T MRI compatibility for the Genio system. MRI scans are often the preferred diagnostic imaging modality for comorbidities affecting OSA patients. This extensive MRI labeling will be a major benefit for all OSA patients who currently receive the Genio therapy in the United States as part of the DREAM IDE clinical trial, ensuring that they can undergo MRI scans in full safety.”