SenSight Directional Lead System Approved for DBS Therapy

The FDA has approved Medtronic’s SenSight Directional Lead System for deep brain stimulation (DBS) therapy to treat symptoms associated with movement disorders such as Parkinson disease (PD), dystonia and essential tremor, and medically refractory epilepsy.¹

SenSight is the first directional, sensing-enabled lead designed to enhance the detection of local field potentials (LFPs), which are brain signals that correlate with the severity of PD symptoms and are 1 million times smaller than DBS stimulation pulses. The product has already received CE mark and was fully launched in Western Europe in March 2021.

"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, MD, professor of neurosurgery, University of Florida, said in a statement.¹ "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."

Features of the system include a proximal end of lead inserted into an extension, laser-etched markers on the proximal end for identification of left and right leads with bilateral implants, and laser-etched insertion line on the lead body, which provides visual confirmation of complete insertion and thus providing confidence in the connection.²

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The SenSight extension comprises of a single set screw connection on a non-active contact to minimize steps and protect therapeutic delivery. A radiopaque marker is visible under computed tomography (CT), fluoroscopy, X-ray, and the O-arm Imaging System, for distinguishing with bilateral implants.

When paired with the Percept PC device, Medtronic’s other previously FDA-approved DBS system, SenSight expands on the company’s BrainSense technology, enabling clinicians to capture and record enhanced, directional LFP information from the implanted lead. By detecting LFPs, clinicians can correlate these brain signals with stimulation and events capturing medication, symptoms, and adverse effects and thus deliver personalized, data-driven therapy and adjust as the 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,” Leonardo Almeida, MD, assistant professor of neurology, University of Florida, said in a statement.¹ "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.”

The Percept PC DBS system received approval in June 2020 and is indicated to treat patients with neurologic disorders associated with PD, essential tremor, dystonia, epilepsy, or obsessive-compulsive disorder.³ It is currently the only DBS system that is eligible to be used for both 3T and 1.5T full-body magnetic resonance imaging (MRI) scans. The device also offers low pulse width, and an Enhanced Patient Programmer function, which utilizes a user-friendly, custom-configured Samsung mobile device that allows patients to manage their therapy.

Medtronic’s ADAPT-PD (Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease) trial, announced in January, will evaluate the safety and efficacy of adaptive DBS (aDBS) in patients with PD.⁴ If approved, aDBS will be added to the Percept device and would allow for the automated adjustment of DBS to provide therapy to manage symptoms of PD based on a patient’s clinical state.

REFERENCES

1. FDA Approves first-of-its-kind SenSight Directional Lead System for DBS Therapy. News release. June 7, 2021. Accessed June 11, 2021. https://newsroom.medtronic.com/news-releases/news-release-details/fda-approves-first-its-kind-sensighttm-directional-lead-system

2. SenSight Directional Leads. Medtronic. https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/deep-brain-stimulation-systems/sensight-lead.html. Accessed June 11, 2021.

3. FDA Approves First-Of-Its-Kind Percept™ PC Neurostimulator with BrainSense™ Technology. News release. Medtronic. June 25, 2020. Accessed June 11, 2021. globenewswire.com/news-release/2020/06/25/2053361/0/en/FDA-Approves-First-Of-Its-Kind-Percept-PC-Neurostimulator-with-BrainSense-Technology.html

4. Medtronic launches first-of-its-kind adaptive deep brain stimulation (aDBS) Trial in Parkinson's Disease patients. News release. Medtronic. January 14, 2021. Accessed June 11, 2021. https://www.prnewswire.com/news-releases/medtronic-launches-first-of-its-kind-adaptive-deep-brain-stimulation-adbs-trial-in-parkinsons-disease-patients-301207921.html