FDA approves Medtronic’s SenSight directional Lead System for DBS therapy

June 7, 2021  –  Medtronic plc (Dublin, Ireland) announced FDA approval and first U.S. implants of the SenSight Directional Lead System used for Deep Brain Stimulation (DBS) therapy.

According to Medtronic, SenSight is the first-of-its-kind DBS directional lead that combines the benefits of directionality with the power of sensing, allowing physicians to deliver precise, patient-specific DBS therapy for the treatment of some symptoms associated with movement disorders like Parkinson’s disease, dystonia and essential tremor, and medically refractory epilepsy.

Previously, sensing capability and directional leads were not available in the same DBS system, so practicioners had to choose one technology or the other, based on the predicted needs of each patient.

SenSight directional lead systems were first implanted at the University of Florida, by multi-disciplinary teams in early June, and a full launch in the U.S. will immediately follow today’s announcement. The product also recently received CE Mark and fully launched in Western Europe in March of 2021.

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