Medtronic Receives CE Mark Approval for SenSight Directional Lead System for DBS Therapy


Medtronic plc, the global leader in medical technology, announced the CE (Conformité Européenne) Mark for the SenSight™ directional lead system for Deep Brain Stimulation (DBS) therapy as treatment of symptoms associated with movement disorders and epilepsy. DBS is a therapy in which a small pacemaker-like device sends electrical signals through very thin wires, known as “leads,” to a targeted area in the brain related to symptoms. The SenSight directional DBS lead system works seamlessly with certain Medtronic neurostimulators, including the recently-approved Percept™ PC neurostimulator. This system will enhance detection of local field potentials (LFPs) and offers directional stimulation to provide individualized and patient-specific data plus additional programming features to tailor therapy for patients.

“This is the only directional lead with built-in sensing capabilities,” said Jens Volkmann, M.D., Ph.D., FEAN, chairman and professor of neurology in the University Clinic of Wu?rzburg. “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 personalized therapy, which we can adapt using the objective data from each patient to inform programming in ‘space and time.'”

With collaboration and insights from clinicians, Medtronic engineers have designed every component of the SenSight system to meet customer and patient needs and work seamlessly with the Percept PC neurostimulator to enhance detection of local field potentials (LFPs), which are 1 million times smaller than DBS stimulation pulses.1

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

SenSight directional lead systems were first implanted at the University Clinic of Würzburg and Grenoble Alpes University Hospital, by multi-disciplinary teams on March 17 and 18, and a full launch in Western Europe will immediately follow today’s announcement. The product is currently under review by the U.S. Food and Drug Administration.

“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,” said Mike Daly, vice president and general manager of Brain Modulation within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. “Our commitment to evolving DBS therapy is unwavering and we look forward to introducing additional advancements in 2021 and beyond.”