Aleva Neurotherapeutics has announced CE-mark approval of its magnetic resonance imaging (MRI) labelling for the directSTIM deep brain stimulation (DBS) system, allowing the technology to be used in a full-body MRI environment across Europe.
The directSTIM system, featuring a fully directional lead, is designed to treat the symptoms of Parkinson’s disease by delivering precisely targeted electrical stimulation to the brain, providing optimal symptom relief and better control of unwanted side-effects—as per an Aleva press release.
This recent CE marking allows patients to undergo a full-body 1.5 Tesla MRI, when all conditions of use are met, while benefitting from the latest advances in DBS therapy, including directional stimulation and a longer-lasting rechargeable battery.
Alain Jordan, Aleva CEO, said: “This is an important milestone for Aleva that supports our market expansion in Europe by making the directSTIM system available to a new category of patients who are likely to undergo an MRI exam after DBS surgery.”
In February this year, approval was granted by the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) study of the directSTIM DBS system.