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Medtronic’s directional lead system obtains CE Mark for DBS

23 Mar 2021 (Last Updated March 23rd, 2021 10:39)

Medtronic has received the CE Mark for its SenSight directional lead system for deep brain stimulation (DBS) therapy to treat symptoms linked to movement disorders and epilepsy. 

Medtronic’s directional lead system obtains CE Mark for DBS
DBS is a therapy in which a small pacemaker-like device uses thin wires known as leads to send electrical signals to a targeted region in the brain associated with symptoms. Credit: Robina Weermeijer on Unsplash.

Medtronic has received the CE Mark for its SenSight directional lead system for deep brain stimulation (DBS) therapy to treat symptoms linked to movement disorders and epilepsy.

This system will boost the identification of local field potentials (LFPs) and provide directional stimulation to offer customised and patient-specific data, as well as further programming features to personalise treatment for patients.

The SenSight directional DBS lead system works effortlessly with some Medtronic neurostimulators such as the Percept PC neurostimulator.

Medtronic brain modulation vice-president and general manager Mike Daly said: “Medtronic has been driving innovation in DBS therapy for more than 25 years and the approval of the SenSight directional lead system in the EU is our latest contribution to the quest for improved patient experiences and clinical outcomes.”

Last week, multi-disciplinary teams implanted SenSight directional lead systems at the University Clinic of Würzburg and Grenoble Alpes University Hospital.

Grenoble Alpes University Hospital professor Stéphan Chabardès said: “The new lead system and supporting technology has been designed with the patient, neurosurgeon and programming neurologist in mind.

“What may seem like small changes to materials, design and technology will actually result in meaningful improvements in things like precisely delivering stimulation to each individual patient, streamlining the surgical procedure, and capturing objective data for more efficient, informed programming.”

Medtronic noted that the system will be fully introduced in Western Europe soon. It is currently being reviewed by the US Food and Drug Administration (FDA).

DBS is a therapy in which a small pacemaker-like device uses thin wires known as leads to send electrical signals to a targeted region in the brain associated with symptoms.

Earlier this month, the US FDA issued a Class I recall of Medtronic’s HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit, following several complaints.