There are two main types of brain stimulation devices: Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS) devices. DBS medical devices treat neurological disorders, such as Parkinson’s disease, essential tremor, and other neuropsychiatric conditions. Specifically, DBS devices require an invasive surgery that involve physicians implanting one or more electrodes or “leads” into targeted regions of the brain. The leads are connected to a small neurostimulator that is generally implanted near the patient’s collarbone. The neurostimulator generates electrical impulses that are transmitted via thin insulated extension wires to the leads implanted in the brain. The signals delivered help to reduce and modulate abnormal brain electrical activity associated with a particular neurological disorder that is not adequately controlled with medication.[1] Because of the invasiveness of the implantation process and the risks this involves, DBS devices are regulated by FDA as class III products that require Premarket Approval (PMA) review.
TMS devices, however, are used to non-invasively stimulate the brain to treat neuropsychiatric conditions, such as major depressive disorder (MDD) and obsessive compulsive disorder (OCD). TMS devices have also been approved for other indications including smoking cessation and migraines. A typical TMS device consists of an electromagnetic coil that is placed adjacent to a patient’s scalp in a specific configuration (e.g., figure 8 or butterfly shape) and is used to generate a magnetic field that induces and delivers electrical currents to underlying brain tissue. When delivered at appropriate thresholds, durations, and repetitive magnetic pulses, the fields stimulate nerve cells in the brain. Exciting these cells trigger the development of neuronal pathways in parts of the brain affiliated with MDD and OCD, helping to normalize brain activity in these regions and alleviate symptoms associated with the disorders.[2] Because these devices are non-invasive, they are regulated by FDA as class II products that require premarket notification, or “510(k) Notice,” review.
While DBS and TMS devices present different risks, both allow for customization of treatment parameters by trained healthcare professionals in delivering targeted therapy to meet a patient’s individualized needs. Significant recent advancements in technologies for both therapies incorporate the use of software, whether as a component of the overall device or as a standalone system, to set stimulation parameters for precise and personalized treatment. When used in conjunction with image-guided software, a user’s ability to visualize lead placement in real time and stimulation modeling of a patient’s brain anatomy is further enhanced.
Recent Deep Brain Stimulation device approvals
Boston Scientific carries a line of Deep Brain Stimulation devices, and has received premarket approval (PMA) for several devices within its DBS product line, including:
- The Vercise PC Deep Brain Stimulation (DBS) System, approved by FDA on January 10, 2019, through a PMA supplement.
- The Vercise Gevia Deep Brain Stimulation (DBS) System, approved by FDA on January 10, 2019, through a PMA supplement.
- The Vercise Genus Deep Brain Stimulation (DBS) System, approved by FDA on January 21, 2021, through a PMA supplement.
Each of these devices comprise of an implantable pulse generator (IPG), a clinician programmer, a remote control for patients, and lead and extension kits.[3] In all of these devices, an implanted pulse generator connects to implanted leads. Electrical pulses originating from the IPG are transmitted through the leads to specific areas of the brain.[4]
FDA first approved the Vercise Deep Brain Stimulation (DBS) System in 2017 as a class III device through the premarket approval regulatory pathway. The agency has since approved these devices for several uses, including:
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Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson’s disease (PD) that are not adequately controlled with medication.
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Bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy in reducing some of the symptoms of advanced levodopa-responsive Parkinson’s disease (PD) that are not adequately controlled with medication.
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Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.[5]
In July 2023, FDA approved the Vercise Neural Navigator 5 software, as a PMA supplement — the latest iteration of Boston Scientific’s Vercise Neural Navigator software, indicated for use with the company’s Vercise Genus devices for Parkinson’s and essential tremor.
The Neural Navigator 5 software provides streamlined patient data, including outputting a visual of a patient’s brain anatomy. High-resolution brain imaging data, e.g., from MRI scans, are used by the software to generate 3D models of the patient’s brain. When using this software, providers have more opportunity to ensure precision and accuracy in the therapy provided to patients by identifying exact region(s) of the brain to be stimulated. The software also relays real-time feedback, allowing providers to monitor and adjust treatment parameters as needed to optimize treatment. Additionally, the software significantly decreases programming time, giving providers more flexibility in their schedules to interact with and assist patients.[6]
Most recently, FDA announced a new regulatory review period for the Vercise DBS System.
Applicability of software approval to non-DBS devices
Devices involving brain stimulation are regulated by FDA through various classifications and regulatory pathways, which include premarket approval, de novo, or 510(k) notices.[7] FDA generally regulates transcranial magnetic stimulation devices as class II devices, mandating certain general and specific controls to ensure patient safety. [8] Class II devices can be cleared through de novo or 510(k) pathways.
FDA’s approval of the Neural Navigator 5 software highlights software’s expanding approval to enhance brain stimulation devices. Software that pairs with DBS, or TBS devices, can potentially receive FDA clearance or approval through relevant regulatory pathways. This software can improve a clinician’s use of paired devices through improved data metrics and patient-specific targeted therapy.
Next steps
As image-guided software technologies in brain stimulation evolve, given their complexities, they require a thorough understanding of the applicable FDA regulatory landscapes through which such products are reviewed.
Brain stimulation devices, and device-paired software, treat a variety of conditions. As these devices are approved, more patients will receive the treatment they need to reduce challenging symptoms associated with these conditions.
If you have any questions on FDA approval standards for DBS or TBS devices, or on 510(k) submissions more generally, feel free to contact the Hogan Lovells attorney with whom you regularly work, or either of the authors of this alert.
Authored by Randy Prebula and Sanchita Bose
