The company claims that SenSight is the first directional lead system to combine the benefits of directionality and sensing capabilities
Medtronic gets CE Mark approval for SenSight system. (Credit: Sébastien Bertrand/Wikipedia.)
Medtronic has secured the CE Mark approval for its SenSight directional lead system for deep brain stimulation (DBS) therapy.
The European regulator indicated the SenSight system for treating symptoms related to movement disorders and epilepsy.
DBS therapy involves a small pacemaker-like device that sends electrical signals through very thin wires, dubbed ‘leads’, to a targeted area in the brain associated with the symptoms.
Medtronic vice president and neuroscience portfolio 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.
“Our commitment to evolving DBS therapy is unwavering and we look forward to introducing additional advancements in 2021 and beyond.”
Medtronic said that its SenSight directional DBS lead system is compatible with certain Medtronic neurostimulators, including the CE mark approved Percept PC neurostimulator.
Also, the system would enhance the detection of local field potentials (LFPs) and provides directional stimulation to facilitate patient-specific data and customised therapy for patients.
The company said that with collaboration and insights from clinicians, every component of the SenSight system has been designed to meet customer and patient needs.
The system works with the Percept PC neurostimulator to enhance the detection of LFPs, which are 1 million times smaller than DBS stimulation pulses.
SenSight systems were first implanted at the University Clinic of Würzburg on 17 March, and Grenoble Alpes University Hospital on 18 March.
The system is currently under review by the US Food and Drug Administration and will be fully launched in Western Europe immediately.
University Clinic of Würzburg chairman and neurology professor Jens Volkmann said: “This is the only directional lead with built-in sensing capabilities.
“The challenge of DBS is to provide stimulation to a very small brain region only at times, when fluctuating symptoms require treatment.
“This new technology holds promise for a truly personalised therapy, which we can adapt using the objective data from each patient to inform programming in space and time.”