FDA Clears Next-Generation DBS System for Movement Disorders

Megan Brooks

June 08, 2021

The US Food and Drug Administration (FDA) has approved Medtronic's technologically advanced deep brain stimulation (DBS) system designed to more precisely target motor symptoms in Parkinson's disease, dystonia, or essential tremor.

The SenSight Directional Lead System for DBS therapy combines two recent advancements: sensing capability that allows real-time monitoring of brain signals to optimize settings for stimulation, and a "directional lead" that enables steering of electric current for more precise targeting of stimulation through the electrode.

"Until now, sensing capability and directional leads have not been available in the same DBS system, so we have had to choose one technology or the other, based on the predicted needs of each patient," neurosurgeon Kelly Foote, MD, who performed the first implant of the SenSight System at University of Florida (UF) Health, said in a news release.

"Now, by coupling this new directional lead with a pulse generator capable of brain sensing, we are excited to be able to offer our patients the synergistic benefits of both technologies," added Foote, co-director of the Norman Fixel Institute for Neurological Diseases at UF Health.

Foote said DBS systems capable of adjusting therapeutic stimulation in response to continuously recorded brain signals may lead to better DBS outcomes with fewer adverse effects.

"Adding a directional lead to such a system will improve our ability to localize abnormal signals and enable us to steer current more effectively to areas in the brain where it is most beneficial," Foote said.

"We are excited to see the clinical benefits that the new SenSight directional lead system will provide to patients and physicians in the US," added Mike Daly, vice president and general manager of brain modulation at Medtronic.

Medtronic's SenSight directional lead DBS system received CE Mark approval in Europe in March.

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