CE Mark For Nexstim’s Brain Therapy To Treat Depression And Stroke Rehab

In short

Finnish device company Nexstim Oy, has announced that its Navigated Brain Therapy (NBT) System has gained CE mark clearance. The NBT System is the first non-invasive, non-systemic therapeutic device CE-marked to offer patients a personalised treatment for major depression and is also indicated for use in patients recovering from stroke as a supplement to conventional rehabilitation.

Background

Founded in 2000, Nexstim set about developing navigated transcranial magnetic stimulation (TMS) solutions for non-invasive brain therapy and diagnostics. NBT works by using a TMS coil placed over the patient’s head to gently activate neurons in the underlying cortex. MR-images of the brain are used to visualise the stimulating electric field and allow the user to precisely modulate any desired brain structure.  This guidance system means stimulation therapy to be personalised and quantified to the needs of the individual patient, accurately targeting therapy directly to the cortical structures believed to be involved in brain dysfunctions.

In treating depression, pulsed magnetic fields are used to stimulate a specific region of the cerebral cortex believed to be crucial for the control of mood and associated with depression. This non-invasive, navigated brain therapy has been shown to be safe, well-tolerated and without the side-effects frequently associated with oral antidepressants. A course of therapy with NBT is a painless outpatient procedure and is typically performed in the physician’s office.

Regulatory status 

The NBT System has not received clearance from the FDA for marketing in the USA.

Source: Nexstim Oy, Business Wire