New Sensing and Stim Devices Expand Epilepsy Market
by James Cavuoto, editor
December 2019 issue
The market for treating epilepsy and related seizure disorders stands to expand considerably in coming years. Several recent developments highlight progress in both commercial product development and clinical research. Technological advances in this field include both enhanced neurosensing systems as well as neuromodulation systems.
At the American Epilepsy Society meeting earlier this month, NeuroPace, which makes a closed-loop sensing/stimulation system, presented results from their multicenter, retrospective study of 150 patients. Patients receiving the company’s RNS device experienced 67 percent median seizure frequency reduction at one year and 75 percent at two years. More than one in three patients achieved greater than 90 percent seizure reduction.
Another key player in the epilepsy market is FHC, Inc. in Bowdoin, ME. The company recently released a joint announcement with Neurotargeting LLC for the WayPoint Navigator 4.5 planning software, which allows epileptologists, neurosurgeons, and the epilepsy monitoring unit staff to aggregate the wide variety of information collected while a patient with epilepsy progresses from diagnosis through treatment stages. The software combines EMU foci localization results and post SEEG CT scans to create a complete 3D visualization of segmented lead, structures and seizure spread. FHC’s Multi-Oblique Epilepsy Platform is a single patient-specific stereotactic fixture that allows SEEG electrode implantation in minimal time by providing simple/quick setup and simultaneous access to all trajectories. The system works with electrodes and implantation tools from Ad-Tech Medical, PMT, DIXI Medical, Integra, and others.
Another new player, Ceribell, Inc. in Mountain View, CA, recently announced the launch of Clarity, a new 24/7 bedside EEG monitoring and alerting technology. Used with the Ceribell Rapid Response EEG system, Clarity automatically detects seizures and alerts clinicians for the presence of brain activity consistent with status epilepticus. The system’s signal quality is equivalent to more complex conventional systems, and it includes the Brain Stethoscope feature to spot-check for seizures and Clarity for automatic and continuous seizure monitoring.
Yet another new player is NeuroOne Medical Technologies Corp. in Eden Prairie, MN, which is commercializing thin film electrode technology for recording from and stimulating brain tissue. The company announced that it received FDA clearance to market its thin film cortical electrode technology for temporary recording, monitoring, and stimulation on the surface of the brain. The Evo cortical electrode product line is the result of a collaboration with both Wisconsin Alumni Research Foundation and Mayo Foundation for Medical Education and Research.
Meanwhile, a team at Georgetown University Medical Center have found, in animal models, that they can “switch off” epileptic seizures. The findings, published in PNAS, provide the first evidence that while different types of seizures start in varied areas of the brain, they all can be controlled by targeting a very small set of neurons in the brain or their tendril-like neuronal axons. Zeroing in on specific neurons suggests that treatment for epilepsy can be improved, researchers say. For example, DBS could be minutely targeted at the cell body of these neurons or at the areas their axons touch, depending on the type of seizure, says the study’s senior investigator, Patrick Forcelli, an assistant professor in neuroscience and in pharmacology and physiology at Georgetown. “We have found a major choke point in epilepsy circuits in rat brains that we believe can be harnessed to disrupt the onset of seizures or to stop their propagation within the brain,” he says. “Circuit-based therapy for people will help offset the known side effects that come with drug therapy and other techniques.”
His team was able to stop seizures by placing light-sensitive ion channels into neurons in the substantia nigra pars recticulata; when exposed to light, the neurons can be turned on or off. They found that seizures could be turned off by either silencing activity of the SNpr cell bodies or, in some cases, the areas these neurons project to.
For all the positive developments in the neurotech epilepsy space, there was also one negative. The FDA recently issued a Class I recall of LivaNova’s Sentiva VNS device, citing reset problems.