Therapy Areas: Devices
Medtronic awarded FDA approval for first implants of the SenSight Directional Lead System for Deep Brain Stimulation therapy
8 June 2021 -

Medical technology company Medtronic plc (NYSE:MDT) reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for first US implants of the SenSight Directional Lead System for Deep Brain Stimulation (DBS) therapy.

The Irish company said DBS is a therapy in which a small pacemaker-like device sends electrical signals through very thin wires to a targeted area in the brain related to symptoms of certain neurological disorders. A few weeks after surgery, the neurologist will wirelessly adjust the neurostimulator setting to best control symptoms while minimizing potential side effects in a process known as programming.

According to the company, 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 including Parkinson's disease, dystonia and essential tremor and medically refractory epilepsy.

As part the SenSight directional lead system, the company redesigned the lead system, with the patient, neurosurgeo, and programming neurologist in mind. SenSight is the first directional, sensing-enabled lead designed to enhance the detection of local field potentials, which are brain signals that correlate with the severity of Parkinson's disease symptoms and are 1m times smaller than DBS stimulation pulses.

In early June, SenSight directional lead systems were first implanted at the University of Florida and is now expected to be launched in the US. The product received CE Mark and was fully launched in Western Europe in 2021, concluded the company.

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