FDA Approves Advanced DBS System Allowing More Personalized Care

The U.S. Food and Drug Administration (FDA) has approved Medtronic‘s SenSight Directional Lead System, which offers both sensing and directional capabilities allowing for more precise use of deep brain stimulation (DBS), a widely approved surgical treatment for Parkinson’s disease.

The first SenSight directional lead systems were implanted in a patient at the University of Florida this month, and the system is now being launched across the U.S., Medtronic reported.

The system also recently received CE Mark —  a designation issued by the European Commission, indicating a product meets certain safety, health, and environmental protection requirements — and it launched in Western Europe earlier this year.

“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.,” Mike Daly, vice president and general manager of brain modulation within the neuromodulation business at Medtronic, said in a press release.

In DBS, a small pacemaker-like device is surgically implanted in a patient and delivers electrical signals to specific parts of the brain through very thin wires known as “leads.” A few weeks after the device is surgically implanted, a specialist will wirelessly adjust the device for optimal settings to control symptoms and minimize side effects.

The SenSight system is reported to be a first-of-its-kind technology, which combines a directional lead — meaning a lead that allows more specificity in exactly where electrical signals are sent in the brain — with the ability to measure local field potentials.

Local field potentials, or LFPs, are brain signals that are associated with the severity of Parkinson’s symptoms, and are about one million times smaller than the electrical signals used in DBS. By allowing clinicians to measure LFPs, the SenSight system aims to make it easier to deliver personalized therapy based on an individual patient’s needs, and to make appropriate adjustments over time.

“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. 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,” said Kelly D. Foote, MD, a professor of neurosurgery at the University of Florida.

Since the device is implanted surgically, it will be able to continuously record LFPs as patients go about their day.

“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,” Foote said.

“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,” added Leonardo Almeida, MD, an assistant professor of neurology at the university.