FDA Approves Medtronic’s SenSight Directional Lead System for DBS

The U.S. Food and Drug Administration (FDA) approved Medtronic’s SenSight Directional Lead System used for Deep Brain Stimulation (DBS) therapy, and the technology was used in its first surgeries. SenSight is the first-of-its-kind DBS directional lead that combines directionality with sensing, allowing precise, patient-specific DBS therapy to treat some symptoms of movement disorders like Parkinson’s disease, dystonia and essential tremor, and medically refractory epilepsy.
 
“Until now, sensing capability and directional leads have not been available in the same DBS system, so we have had to choose one technology or the other, based on the predicted needs of each patient,” Kelly D. Foote, M.D., professor of neurosurgery at University of Florida told the press. “Now, by coupling this new directional lead with a pulse generator capable of brain sensing, we are excited to be able to offer our patients the synergistic benefits of both technologies. Furthermore, the ability to continuously record brain activity while affected patients go about their daily lives is a powerful research tool that is rapidly improving our understanding of these brain circuitry disorders that diminish the lives of so many people.”
 
For the SenSight directional lead system, Medtronic reimagined how a lead system could be designed, with the patient, neurosurgeon, and programming neurologist in mind. Deliberate choices related to materials and design were made to enhance comfort for patients, allow for more precise stimulation, and streamline the surgical procedure—all while being able to capture objective data for more efficient, informed programming.
 
SenSight is designed to enhance detection of local field potentials (LFPs), brain signals that correlate with the severity of Parkinson’s disease symptoms and are 1 million times smaller than DBS stimulation pulses¹. When paired with the Percept PC device, SenSight expands on BrainSense technology, enabling clinicians to capture and record enhanced, directional LFP information from the implanted lead. When physicians can detect LFPs, they can correlate these brain signals with stimulation and events capturing medication, symptoms, or side effects to deliver personalized, data-driven therapy and adjust this therapy as patient needs evolve.
 
“We are learning from studies across the globe as well as daily patient care that knowing the absolute best location to implant a lead can provide both very efficient and efficacious stimulation,” said Leonardo Almeida, M.D., assistant professor of neurology at University of Florida. “The more we continue to learn about signals from different diseases and where they are located in relation to where we usually target an implant, the more healthcare teams will be able to refine targeting and accurately plan electrode positioning for each specific 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.
 
“We are excited to see the clinical benefits that the new SenSight directional lead system will provide to patients and physicians in the U.S.,” said Mike Daly, vice president and general manager of Brain Modulation within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. “For over 25 years, Medtronic has driven discoveries and advancements in DBS therapy and we look forward to continuing to deliver meaningful innovation to the movement disorder and epilepsy patient communities.”
 
References
¹ Neumann WJ, Staub F, Horn A, et al. Deep brain recordings using an implanted pulse generator in Parkinson’s disease. Neuromodulation. 2016;19(1):20-24.