Vercise DBS receives breakthrough device designation from FDA

Deep Brain Stimulation of the fornix (DBS-f)

Functional Neuromodulation has announced that the Vercise deep brain stimulation (DBS) device, developed and manufactured by Boston Scientific, has received breakthrough device designation from the US Food and Drug Administration (FDA). The device is aimed for treatment of patients with Alzheimer’s disease.

According to a press release by the company, the breakthrough device designation will provide priority review regarding device development and assessment to help provide patients and healthcare providers gain timely access to medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Todd Langevin Functional Neuromodulation CEO (Minneapolis, USA) comments: “There is an urgent need for new ways to treat Alzheimer’s. Pharmacological therapies have shown very limited benefit, and some have considerable side effects. DBS is a promising alternative with a safe and successful track record in other neurological disorders. For Alzheimer’s, DBS-f delivers stimulation to a critical location in the brain’s memory circuit that seems to enhance activity in the circuit and drive neuronal activity in other brain regions impacted by the disease. We are encouraged to receive Breakthrough Device Designation.”


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