The Food and Drug Administration (FDA) has approved Medtronic’s SenSight™ directional lead system for deep brain stimulation (DBS) therapy.

DBS therapy consists of a small pacemaker-like device implanted under the skin of the chest or abdomen that delivers electrical stimulations through leads to a targeted area in the brain. The SenSight directional lead system is the first directional, sensing-enabled lead designed to enhance the detection of local field potentials (LFPs). 

The system works with Medtronic’s Percept™ PC Neurostimulator with BrainSense™ technology to enhance the capturing and recording of LFP information from the implanted lead. This allows physicians to individualize DBS therapy to treat certain symptoms associated with movement disorders such as Parkinson disease, dystonia and essential tremor, and medically refractory epilepsy.

“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,” said Kelly D. Foote, MD, professor of neurosurgery at University of Florida. “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.”


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The SenSight directional DBS lead system is now available in the US.

Reference

FDA approves first-of-its-kind SenSight™ Directional Lead System for DBS Therapy. [press release]. Dublin, Ireland: Medtronic plc; June 7, 2021.