Functional Neuromodulation Announces Breakthrough Device Designation from the U.S. FDA for Deep Brain Stimulation for Alzheimer’s Disease

February 3, 2021
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Functional Neuromodulation announced today that it has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for the Vercise™ Deep Brain Stimulation (DBS) Systems, developed and manufactured by Boston Scientific Corporation, in the treatment of patients 65 years and older with mild probable Alzheimer’s disease. 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.

Alzheimer’s disease, the most common form of dementia, is a progressively debilitating disease representing the fifth-leading cause of death among those 65 and older in the United States.ii Worldwide, at least 50 million people are estimated to be living with Alzheimer’s disease or other dementias.iii Alzheimer’s disease is without an identified way to prevent, cure or even slow its progression.

Designed to evaluate the safety and efficacy of DBS of the fornix (DBS-f) for patients with mild Alzheimer’s disease, the company’s ADvance II pivotal study is currently enrolling up to 210 patients in a randomized, double-blind, controlled trial at leading universities in the U.S., Canada and Germany.

“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,” said Todd Langevin, Functional Neuromodulation CEO.

Under the designation, the Vercise DBS Systems are indicated for unilateral or bilateral stimulation of the post-commissural fornix in the treatment of patients 65 years and older with mild probable Alzheimer’s disease as an adjunctive therapy for patients who are not adequately controlled with medications.

About the ADvance II Study

The study is co-chaired by Constantine Lyketsos, M.D., chair of psychiatry at Johns Hopkins Bayview Medical Center and Andres Lozano, M.D., Ph.D., chair of neurosurgery at the University of Toronto. For more information about the ADvance II Study, visit or

The clinical trial is currently enrolling subjects at 20 study sites within the United StatesCanada and Germany. Cities include PhoenixLos AngelesGainesvilleTampaAustinStanfordBaltimoreProvidenceOmahaWake Forest and Milwaukee in the United States; and Toronto in Canada. As well as CologneKiel, Würzburg, Magdeburg, MunichMannheimHannover and Heidelberg in Germany.

About Deep Brain Stimulation

Deep brain stimulation uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain.  DBS therapy has been commercially available in the United States since 1997. The therapy is currently approved for use in the United StatesCanada and the European Union for the treatment of the disabling symptoms of essential tremor, advanced Parkinson’s disease and epilepsy. More than 150,000 people worldwide have received DBS therapy.

The data from Advance II study is intended to support a U.S. regulatory application. In Europe, the Boston Scientific Vercise™ Directional System is CE marked for adjunctive treatment of patients 65 years and older with mild probable Alzheimer’s disease.

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