CE-Mark for Aleva’s Deep Brain Stimulation

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20.09.2022

After receiving approval from the US Food and Drug Administration, Aleva Neurotherapeutics has obtained the CE approval of its MRI labeling for the directSTIM™ DBS System in Neuromodulation - supporting a new category of patients who are likely to undergo an MRI exam after DBS surgery. The commercial journey has started as the company partners with neurological clinics across Europe.

An estimated ten million people worldwide are affected by Parkinson’s disease, causing symptoms such as shaking or tremors, muscle stiffness, and slowness of movement. DBS therapy helps patients with Parkinson’s disease control their symptoms and improve their quality of life.

Aleva introduced the Directional mode of Deep Brain Stimulation (DBS) to Neuromodulation treatments. Its directSTIM™ system, featuring a fully directional lead, is designed to treat the symptoms of Parkinson’s Disease by delivering precisely targeted electrical stimulation in the brain to provide optimal symptom relief and better control of unwanted side effects. The clinically proven technology has set the industry standard for directional leads. Aleva’s expertise in DBS technologies for neurological and psychiatric diseases is demonstrated by 13 patent families and 90 granted patents in this area.

In February this year, approval was granted from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) study. With the receipt of the CE-marking for its directSTIM™, patients can undergo a full-body 1.5 Tesla MRI when all conditions of use are met while benefiting from the latest advances in DBS therapy, including directional stimulation and a longer-lasting rechargeable battery.

The EPFL Spinoff has also started its commercial journey by partnering with the leading neurological clinics in Europe, aiming to penetrate the most relevant worldwide markets in the near future.

Alain Jordan, CEO, says “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.”

(Press release/RAN)

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