The Abbott DBS System, often called the Infinity DBS System, is a deep brain stimulation option that is used to help some people with primarily with movement disorders when medications are no longer effective on their own.² ³ The Infinity DBS works by sending small, adjustable electrical pulses through implanted leads to specific brain targets, with the goal of easing certain movement symptoms while your care team fine-tunes settings over time.¹ ² Abbott’s system is known for features like directional lead options, which can help clinicians shape stimulation more precisely for some people, depending on lead placement and symptom goals.³ ⁴ This FAQ provides more indepth information about how the Abbott system is built, what it is approved to treat in the US, and what questions can help you and your care team decide what “good fit” looks like for your life and priorities.² ³ What is the Abbott DBS System? The Abbott DBS System is a deep brain stimulation system, a set of implanted parts that sends small electrical pulses to specific brain areas to help reduce certain movement symptoms.¹ ² DBS is not a cure, it is a long-term therapy that is adjusted over time to balance symptom relief and side effects.² ¹⁷ What parts make up an Abbott DBS system? Most DBS systems have three main parts:² • Leads: thin wires placed in the brain target area • Extensions: thin insulated wires that connect the leads to the battery • IPG (implantable pulse generator): the battery and computer, usually placed under the skin in the chest Abbott’s Infinity DBS System also includes external tools used for care: • Clinician programmer: the clinician’s device and software used to program settings⁴ • Patient controller app: the patient-facing tool to check therapy status and use clinician-approved options, such as switching between prescribed programs⁴ ¹⁵ What conditions is the Abbott Infinity DBS System approved to treat in the United States? In the US, the Abbott Infinity DBS System is indicated for:⁴ ⁵ • Parkinson’s disease: bilateral stimulation of the STN (subthalamic nucleus) or GPi (internal globus pallidus) as an add-on therapy to reduce some symptoms in advanced, levodopa-responsive Parkinson’s disease that is not adequately controlled by medications • Essential tremor: unilateral or bilateral stimulation of the VIM (ventral intermediate nucleus) of the thalamus to suppress disabling upper-extremity tremor in adults whose tremor is not adequately controlled by medications and causes significant functional disability It's important to know that DBS approvals, device models, and feature availability can differ by country. If you are outside the US, ask your clinician what is approved where you live, and which device options are available locally.⁷ What do STN, GPi, and VIM mean, and why do “targets” matter? A “target” is the specific brain area where the lead tip is placed. Different targets can help different symptoms, and the best target can vary from person to person.² For the Abbott Infinity DBS System, the FDA-listed targets include:⁴ ⁵ • STN target and GPi target: used in Parkinson’s disease indications • VIM target: used in essential tremor indications If you are deciding between targets, an empowering question is: “Which symptoms are we trying to improve most, and which target best matches that goal for me?” Is the Abbott Infinity DBS System rechargeable? The "FDA Summary of Safety and Effectiveness Data" describes Abbott's Infinity DBS System as a non-rechargeable system, powered by a sealed battery inside a titanium case.⁴ You don't recharge the implanted battery, and when the battery runs low, the IPG may need replacement surgery. The battery life is also dictated by the settings and how much stimulation is used both in time it is active and the amount of milivoltage. Your medical team can estimate a range based on your programmed settings, then track it over time during follow-ups.² ⁴ What is “directional DBS,” and why do people talk about it with Abbott? Directional DBS means the lead can deliver stimulation in a more focused way, not only in a full ring around the lead. With the Infinity system, some electrodes are segmented electrodes, which can be activated independently to steer current toward a desired direction.⁴ ⁸ The FDA SSED describes the 8-contact lead configuration as 1-3-3-1, where the middle two levels are segmented into three parts each, creating expanded programming options and more precise targeting.⁴ Directional leads provide the programming team more “room” to find settings that help symptoms while limiting side effects, but the benefit depends on lead location, symptom goals, and careful programming.⁴ ⁸ How is the Abbott DBS System programmed, and what can patients control? DBS programming is the process of adjusting stimulation settings (such as amplitude, pulse width, and frequency) to improve symptoms while limiting side effects.² ⁴ For Abbott Infinity DBS, the system includes clinician programming tools and a patient controller app.⁴ ¹⁵ Generally speaking, clinicians set and fine-tune the therapy, including safety limits and available options.⁴ Some patients are allowed to do limited actions that the clinician enables, such as checking therapy status or switching between prescribed programs.¹⁵ If you don't know if you are able to change the settings on your own, ask what you can change on your own, what you should never change, and what are concerns that should prompt a call to the clinic. What is “Bluetooth wireless” and “iOS clinician programmer,” and why does it matter? The Infinity DBS system has been described publicly as operating on an iOS software platform with Bluetooth wireless technology for programming and patient control tools which means:⁹ ²² • Programming sessions may use Apple iOS-based clinician devices for the clinician programmer tools⁹ • Patient controller features may be available through iOS devices, depending on what your clinic provides and what is appropriate for your care plan¹⁵ What is the "NeuroSphere Virtual Clinic," and can it support remote DBS programming? NeuroSphere Virtual Clinic is a program described by Abbott as a system that supports virtual visits and, in some cases, remote programming of neuromodulation settings, meaning the clinician can adjust therapy during a remote session instead of only in-person.¹⁰ ¹¹ There is peer-reviewed literature that has discussed this remote tele-programming for DBS and has shown that the NeuroSphere Virtual Clinic has been FDA-approved platform for remote tele-programming.¹² However, not every person is a candidate for remote programming. The availability depends on clinic workflow, licensing, local rules, and your specific device configuration.¹⁰ ¹² Ask your medical team if this new NeuroSphere Virtual Clinic is something you can use when travel is a concern. Can I get an MRI with an Abbott DBS System? Many DBS systems are “MR Conditional,” meaning that haveing an MRI, or CAT Scan, may be possible only under specific conditions and with provable steps to the medical center where you are getting imaging done. You will be asked byt the MRI techs to follow the device-specific MRI instructions, and often they will need to see that your DBS system is set properly to have this MR Conditional setting activated.¹³ Abbott’s MRI support materials emphasize that MRI Mode may need to be enabled and later disabled using a paired patient controller or clinician programmer which is in compliance with most MRI providers. If MRI Mode cannot be disabled due to lost pairing, Abbott notes this could require device replacement surgery to restore therapy.¹³ Before any MRI scheduling, tell the imaging team you have an implanted DBS device, and ask your DBS clinic for the exact MRI instructions for your specific implanted model.¹³ What procedures should I always flag to clinicians, dentists, therapists, and imaging centers? Abbot's DBS System includes important “do not do” items and precautions. For the Infinity DBS System, the FDA SSED lists contraindicated procedures including:⁴ • Diathermy (short-wave, microwave, or therapeutic ultrasound diathermy) • Electroshock therapy • Transcranial magnetic stimulation (TMS) If you are unsure about a procedure, bring your device card, and ask your DBS medical team before hand if getting an MRI will be safe with your system, and what steps should the clinic take. What are common risks or ripple effects people discuss with DBS, in general? DBS is brain surgery, so there are potential risks related to surgery and anesthesia, and there can also be rippole effects related to stimulation that may change when settings change.² ⁴ The FDA has emphasized that improvement will vary from patient to patient, and settings often need time and multiple adjustments to optimize.¹⁷ How do I check if my Abbott DBS device has a recall or safety notice? In the United States, the FDA maintains recall information, including recalls involving the St. Jude Medical Infinity DBS System.¹⁴ What do you do if you have concerns: • Ask your medical team and clinic if they have information for your exact device model numbers and implanted components, which you can find on the medical card you will recieve from Abbott. • You can also search the FDA's recall information, or ask your medical team, to confirm whether any notice applies to your DBS system. • It's recommended to not make changes on your own based only on online information, use it as a starting light, then verify with your DBS team, and this includes this information as well. We will always defer you to your medical team for validating any information on your DBS system. What questions help me compare Abbott DBS with other DBS systems? If you are comparing DBS manufacturers, these questions can help you stay grounded and informed: • Indications: Is my condition and target covered by the FDA, or your governing agency in your country, indication for this system?⁴ ⁵ • Battery style: Is my battery non-rechargeable, and what is the expected replacement timeline for my likely settings?⁴ • Programming flexibility: Will I use directional leads, and what does that change for me in everyday outcomes?⁴ ⁸ • Remote care: Does your medical clinic offer NeuroSphere Virtual Clinic for your medical team for remote handling, and what parts of care can it handle?¹⁰ ¹² • MRI access: What are the MRI conditions for my configuration, and what will I need to bring to appointments?¹³ • Tools: What patient controller app or device will I use, and what is the backup plan if it is lost?¹³ ¹⁵ If I already have the Abbott DBS System, what should I keep in a “DBS go-bag” for appointments or travel? Consider keeping these items together. The case for the controllers usually fit in a purse, or in a backpack, and it should be in a place where you can grab it quickly. Typically what should be readily available are the following: • Your device ID card with model information • The name and phone number of your DBS clinic • Your patient controller device, plus charging cable if you use one¹⁵ • A short note listing your usual DBS programs or settings summary, if your clinic provides one Be sure to ask your medical team what they recommend for your specific configuration. Also it is highly recommended to find out who your Abbott representative is. Get their name and direct phone number. Don't let your medical team keep you from reaching out to your Abbott rep. You have paid for the device, and have every right as your own patient advocate to have direct access in the event your medical team is unavailable. Also provide all of this information to your family or care partner!

Boston Scientific’s DBS System, the Vercise DBS System, is a deep brain stimulation option that uses implanted leads and a small implanted battery, called a stimulator or IPG, to send adjustable electrical pulses to specific brain targets. In the United States, Boston Scientific DBS is FDA-approved for certain people with Parkinson’s disease and for certain tremor indications, when symptoms are not adequately controlled with medication and are significantly affecting daily life, but there may be different applications that the Vercise system is used in regions outside of the United States. As previously mention, DBS is not a cure, but a long-term therapy tuned over time with your medical team, where the aim is for steadier days and fewer side effects by carefully adjusting settings to match your goals. This FAQ will share how the Boston Scientific system is built, what it is approved to treat, and what questions can help you and your care team decide whether it fits your needs and routines. What is the Boston Scientific DBS System? The Boston Scientific DBS System is a deep brain stimulation system, often referred to by their product family name Vercise. As with other DBS systems, it uses implanted leads and a small implanted battery, to deliver adjustable electrical pulses to specific brain targets to help reduce certain movement symptoms.¹ ² Which Boston Scientific DBS models are commonly discussed in the US? In the US, Boston Scientific’s DBS family includes models approved by the FDA. These systems are named "Vercise DBS System" and the "Vercise PC, Vercise Gevia, and Vercise Genus DBS Systems."³ These names are indicative of specific features like battery type and MRI eligibility which can vary by model and by the exact implanted component set.³ ⁴ Internationally outside of the United States, the device names, approved uses, and feature availability can differ, country to country. If you live outside the US, ask your clinician which Boston Scientific DBS models and indications apply where you live.⁵ What conditions is the Boston Scientific DBS System approved to treat in the United States? Based on FDA approvals for the Vercise family, there are two movement disorders used to therapeutic value. However, there are some conditions that the Vercise system may be used in special cases, outside of the FDA. The two FDA approved uses are for:³ ⁶ ⁷ • Parkinson’s disease where bilateral stimulation of the subthalamic nucleus (STN) as an add-on therapy to reduce some symptoms of moderate to advanced levodopa-responsive Parkinson’s disease that is not adequately controlled with medication³ • And, tremors in the unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) where it is used to suppress upper-extremity tremor in people diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications, when tremor causes significant functional disability⁶ ⁷ Again, if you're unsure whether your diagnosis fits an FDA indication, or outside of the United States with your specific governing agency that approves, a clear question for you to ask your team is, “Which FDA indication is my care plan based on, and which target does that match for me?” What do STN and VIM mean, and why do “targets” matter? A "target" is that specific area in your brain where the DBS lead tip is placed. Different targets can help different symptoms, and the best target depends on your diagnosis and your main symptom goals.¹ ² For Boston Scientific’s indications, STN is used for Parkinson’s disease, and VIM is used for tremor indications.³ ⁶ What are the main parts of a Boston Scientific DBS system? DBS systems generally include:¹ ² • Leads: thin wires placed in the brain target • Extensions: insulated wires that connect the lead to the battery • Stimulator or IPG: the implanted battery and “computer” that creates stimulation pulses Boston Scientific’s United States FDA approval also describes external tools used to manage therapy which are: • A handheld remote control used by the patient to interact with the system in clinician-approved ways³ • A clinician programmer using Boston Scientific's "Bionic Navigator" software to set and adjust therapy settings³ • For rechargeable systems, a charging kit to replenish the battery³ What is the difference between rechargeable and nonrechargeable Boston Scientific DBS batteries? Boston Scientific offers both rechargeable and non-rechargeable DBS stimulators, depending on the model.³ ⁸ Let's look briefly at the difference: • Rechargeable: The battery is replenished periodically using a charger provided in the charging kit³ and is typically recharged with a weight balanced shawl with two pockets, one for the weigh and the other for the recharger "puck". Depending on the programming, you will have to recharge either weekly, or every two week which weekly is typically 15-30 minutes and longer for the every two week period. The recharge time is, again, dependent on your programming. • Nonrechargeable: This battery is sealed and is replaced with a minor surgery when depleted, timing depends on settings and usage (your clinic can estimate and track this over time)¹ ³ Typically the manufacturer like to consider the nonrechargable battery to be at 3-5 years, again depending on the programming your medical team has set in your battery. Not everyone has the luxury to choose their DBS system, as some medical teams and neurosurgeons typically lean to one or two systems they will install surgically. Howevery, if you are able to choose a system, here are some practical questions to ask: • “How often might I need to recharge with my likely settings?” • “If I choose nonrechargeable, what is the expected battery life range for my situation?” What are “directional leads,” and how do they relate to Boston Scientific DBS? Directional leads are designed so stimulation can be shaped more precisely, which can help clinicians aim stimulation toward areas that effective for your treated condition, and away from areas that may cause side effects, again depending on lead placement and symptom goals.⁹ Boston Scientific describes directional lead options such as the Vercise Cartesia directional lead as part of the Vercise system family.¹⁰ Now, directional capability can expand programming options, but outcomes still will depend on how accurate the leads are placed, programming specifically for you, and your individual brain anatomy and symptoms.¹ ³ ⁹ What is MICC, and why do some clinicians mention it with Boston Scientific? Boston Scientific describes its DBS systems as using multiple independent current control (MICC), which is nothing more than a way of managing the electricl current across contacts that can support more flexible programming strategies that are unique to you.¹¹ This is a programming and engineering feature, and not a promise of better results for every person.¹ ² ¹¹ If MICC comes up in conversation, ask how would this feature change programming choices for your symptom goals?” How is Boston Scientific DBS programmed, and what can a patient control? Programming is the process of adjusting the DBS settings (such as strength and timing of stimulation pulses) to improve your symptoms while also limiting the potential side effects.¹ ² In the United States, Boston Scientific’s FDA approval is best described as clinician programming using their "Bionic Navigator" software, and patient interaction using a handheld remote control.³ For most patients, the best mindset is to have the clinician set and fine-tune the therapy settings³ while the patient uses the remote control within the limits your medical team has enabled and approved for you to adjust.³ Can I get an MRI with a Boston Scientific DBS system? Some Boston Scientific DBS systems are MR Conditional, meaning that the MRI can be done only when specific conditions are met by the MRI technician and clinic.⁴ ¹² Boston Scientific’s ImageReady information states that the Vercise Genus and the Vercise Gevia systems can be used in MRI and CAT scans when certain conditions are met, including programming the stimulator to special MRI settings.⁴ Boston Scientific’s also states that full-body MRI access can only happend under certain conditions for Vercise Genus.¹² This MRI eligibility will depend on specific Boston Scientific implanted components and in specific MRI conditions. You will always need to confirm your DBS model and follow the device-specific MRI guidelines your DBS team provides.⁴ ¹³ What procedures or exposures should I always flag because I have a DBS implant? DBS approvals include specific warnings and restrictions that can vary by DBS system and geographic region where you live. In general, before any procedures involving strong electrical or magnetic energy, tell the treating team that you have DBS and ask your DBS clinic for device-specific guidance.³ ¹³ This would also include dentists and oral surgeons. Before any procedure, you can ask: • “Is this MRI, CAT Scan, or X-Ray safe with my exact DBS model and lead system?” • “Do I need DBS turned off, switched to a special mode, or checked afterward?” How do I check for Boston Scientific DBS recalls or safety notices? In the United States, the FDA provides recall and safety information for medical devices, including DBS systems. Internationally, other governmental regulatory agencies may have other notification systems or websites, so check in your area, and be sure to ask your medical team. We would recommend that you get your exact implanted model numbers from your medical team, or look at the provided Boston Scientific DBS medical card they provide, then check your regulatory websites, or ask your medical team to confirm whether any notice applies to your specific device set.⁷ What questions help me compare Boston Scientific DBS with other manufacturers? If you are comparing systems, here are some questions to help you make the best decision for you along with your medical team: • Indications and target: Is my diagnosis and target covered by FDA labeling for this system?³ ⁶ • Battery fit: Is rechargeable or nonrechargeable best for me, what does that mean for my daily routine or future replacements, and what does insurance typically approve or not?³ ⁸ • Programming flexibility: Would directional leads or MICC meaningfully work best for my specific symptom goals and treatment?¹⁰ ¹¹ • MRI access: What are the MR Conditional rule that apply to my exact implant configuration?⁴ ¹³ • Tools: What remote control or patient tools will I have access to use, and what happens if it is lost or stops working?³ If I already have Boston Scientific DBS, what should I keep ready for appointments or travel? Consider keeping a simple “DBS essentials” kit which can include: • Your device ID card and implanted model details • Your DBS clinic contact information • Your patient remote control • Any MRI instructions your DBS clinic has provided, if you have them⁴ ¹³ Be sure to ask your medical team what they recommend for your specific configuration. Also it is highly recommended to find out who your Boston Scientific regional representative is. Get their name and direct phone number. Don't let your medical team keep you from reaching out to your Boston Scientific rep. You have paid for the device, and have every right as your own patient advocate to have direct access in the event your medical team is unavailable. Also provide all of this information to your family or care partner!

Medtronic DBS Systems are deep brain stimulation devices used to implanted leads (electrodes) and an implanted battery, called a neurostimulator, to send adjustable electrical pulses to specific brain targets. Many people hear Medtronic system names like the Percept family, Percept PC and Percept RC, which include "BrainSense" features that can record certain brain signals to help inform programming over time.² ³ It's a true "bi-phasic system," that sends and recieves like a traditional computer would. Now, some Medtronic setups also use directional lead options, such as "SenSight," which is designed to help your medical team shape stimulation more precisely when fine-tuning symptoms and side effects.⁴ In 2025, the United States FDA cleared an "adaptive" DBS option for Parkinson’s disease within the Medtronic platform, that is designed to adjust stimulation in response to detected brain activity⁵ Medtronic systems are also labeled MR Conditional, meaning MRI, CAT Scans and X-Rays can be possible under specific device and scan conditions that your DBS team and the imaging center must follow.⁶ This is also true for dentists and oral surgeons. What are Medtronic DBS Systems, in plain language? The Medtronic DBS Systems are surgically implanted medical devices that deliver small electrical signals to specific brain areas (targets) to help treat certain conditions, most often movement symptoms. DBS is a system, not a single part, that includes thin wires, called leads, placed in the brain, with extensions that travel under the skin, and a battery-powered neurostimulator (sometimes called an implantable pulse generator, or IPG) placed under the skin of the chest.¹ Which Medtronic DBS devices are commonly used in the US today? In the US, many Medtronic DBS implants you may hear about fall into two main families: • Percept family: Percept PC (non-rechargeable) and Percept RC (rechargeable).²˒³ • Activa family: Activa PC (non-rechargeable, dual-channel) and Activa RC (rechargeable).⁴˒⁵ Your medical team may also talk about Medtronic leads, including their "SenSight" directional leads that work with the Percept platform.⁶˒⁷ It's important to know that the availability and exact product combinations can vary by country, and under the governing oversight agency where you live and even what DBS system your medical team installs can vary, even within the US.²˒³ What conditions are FDA approved for Medtronic DBS therapy in the US? Medtronic DBS therapy has FDA pathways and approval that cover more conditions than either Abbot or Boston Scientific, even internationally, for these main indications: • Parkinson’s disease (PD).⁸˒⁹ • Essential tremor and parkinsonian tremor.¹⁰˒¹¹ • Epilepsy (as an adjunctive treatment for certain drug-resistant focal seizures in adults).¹²˒¹³ • Dystonia under a Humanitarian Device Exemption (HDE) pathway, which is used for certain rarer conditions.¹⁴ • Obsessive-compulsive disorder (OCD) under an HDE pathway for chronic, severe, treatment-resistant OCD in adults, with specific labeling.¹⁵˒¹⁶ It's also important to note that conditions treated with Medtronic DBS systems may be used in HDE as a special approval that is exempt from the usual “effectiveness” requirements that apply to many devices, and it is based on reasonable assurance of safety and probable benefit.¹⁶ These can include treatment and therapeutic resistent conditions like pain, Multiple Schlerosis tremors, depression, addiction disorders and is currently being researched for other conditions. What brain targets does Medtronic DBS labeling include, and why does that matter? DBS “targets” are those brain areas where the lead contacts will be inserted to and reside. The targets matter because they are tied to FDA approved, an internationally approved indications along with your medical team’s planning. Here are target areas of the most common conditions, disorders and disease states: • Parkinson’s disease: subthalamic nucleus (STN) or internal globus pallidus (GPi).⁸˒⁹ • Tremor: ventral intermediate nucleus of the thalamus (VIM).¹⁰˒¹¹ • Epilepsy: anterior nucleus of the thalamus (ANT).¹²˒¹³ • OCD (HDE): anterior limb of the internal capsule (ALIC), per the HDE approval.¹⁵˒¹⁶ • Dystonia (HDE labeling includes GPi and, in some labeling, STN).¹⁴ You will need to ask your medical team which target is being recommended for you, and how that choice connects to your symptoms and device approval. What is BrainSense technology, and what does “sensing” mean? “Sensing” means the DBS system can record certain brain signals from the implanted lead while also delivering stimulation, like listening while speaking. With the Percept platform, BrainSense is designed to capture brain signals called local field potentials (LFPs).¹⁷˒¹⁸ This matters because it allows your medical team to use these signal trends as one more piece of information when adjusting programming over time. This isn't the same concept as the fictional “mind reading,” and doesn't replace how you feel and function day to day.¹⁷˒¹⁸ What are SenSight directional leads, and what does “directional” mean? The SenSight leads are directional DBS leads with segmented contacts that help shape exactly where the stimulation goes, almost like aiming light through a small adjustable window instead of lighting up everything evenly. Medtronic’s SenSight directional lead system is designed to combine directionality with sensing when used with the Percept platform.⁶˒⁷ Directionality can help your medical team steer the stimulation toward areas with the best therapeutic effect and away from side effects, but the “right fit” depends on individual anatomy, symptoms, and programming needs.⁶˒⁷ What is adaptive DBS (aDBS), and is it part of Medtronic systems? Adaptive DBS (aDBS) is an United States FDA-approved optional programming feature specifically for Parkinson’s disease within the Medtronic Percept system, enabled through clinician programmer software updates. It's important to note that the Percept aDBS is not yet available for other treatable conditions, but there is thought that it may work. This aDBS system is designed to adjust stimulation automatically in response to sensed signals, instead of delivering the same stimulation level all the time, which makes it a unique option for "as needed" milivoltage delivery⁹˒¹⁹ This aDBS is only a clinician-controlled feature, and it is not “set it and forget it.” If you are curious whether aDBS is available or appropriate in your care plan, ask your DBS team: • Is my Medtronic system a Percept neurostimulator that supports aDBS? • Am I eligible based on my diagnosis to have this feature turned on and programmed? • What changes would I notice day to day, and how will we measure benefit?⁹˒¹⁹ Rechargeable vs non-rechargeable: how are Medtronic batteries different? Medtronic offers both rechargeable and non-rechargeable neurostimulators across its DBS lines. Currently the Percept variation that allow rechargable and not are: • Rechargeable: Percept RC, Activa RC.³˒⁵ • Non-rechargeable: Percept PC, Activa PC.²˒⁴ There are some general tradeoffs you might want to talk with your medical team about which include: • Rechargeable devices require regular charging routines.³ • Non-rechargeable devices do not require charging, but eventually require a replacement procedure when the battery runs down.²˒⁴ Your medical team can help you weigh the best lifestyle fit, hand dexterity, comfort with routines, and expected energy needs from your stimulation settings. How does programming work with Medtronic DBS Systems? Programming is the process where medical team adjusts your DBS settings to try to improve symptoms while limiting ripple effects. The settings can include which contacts on the electrodes are active and used, how strong that stimulation is, the pulse width, and finally, the frequency.¹ Medtronic systems use both clinician programming software and patient-facing tools. In the United States the FDA approval documents for the Percept platform include the clinician programmer application and a patient programmer application, plus related telemetry and recharging components (for Percept RC).¹⁹˒²⁰ What this means is basically: • The clinician programming happens typically in clinic, and can evolve over multiple visits. • The patient programmer gives you some limited actions set by your clinician or Medtronic rep with approval of your medical team, like checking battery status or using clinician-approved groups.²⁰ What should I ask my DBS team when choosing a Medtronic system? If you are fortunate to be able to be part of choosing which DBS system you use, here are some questions that you can ask to help your medical team know your thoughts: • Which Medtronic neurostimulator family are you recommending for me, Percept or Activa, and why?²˒⁴ • Which battery best fits my routine, my specific programming needs, and my comfort? Rechargeable or non-rechargeable?²˒³˒⁴˒⁵ • Would a directional lead (like SenSight) help in my specific situation, with my specific conditiona, and what would be the goal of directionality for me?⁶˒⁷ • Would sensing with BrainSense add value for my follow-up care, and how would does that information help you as my medical team to provide bettery therapteutic care for my condition?¹⁷˒¹⁸ • If I have Parkinson’s disease, am I a candidate for adaptive DBS (aDBS) in your clinic, and what is your thought of it being successful for me?⁹˒¹⁹ • How can we plan for any imaging access and safety with my exact device configuration?²¹˒²² What should I know about MRI with Medtronic DBS Systems? MRI safety depends on the exact DBS model, the complete implanted configuration, and following Medtronic's MRI conditions. The Medtronic DBS systems are labeled MR Conditional, which means MRI can be performed, but only under specific conditions, which can include if their imaging machines are compatible with any of the Percept series of DBS systems.²¹ Medtronic materials for Percept do state that certain Percept systems allow DBS therapy to remain on during an MRI scan under specified conditions, and include full-body MRI labeling for 1.5T and 3T within limits.²¹˒²² The imaging center may ask to watch you change your communicatior go into MRI mode before you go back into imaging. Here are more practical steps to consider: • Tell every imaging team you have DBS before scheduling an MRI. • Bring your device ID card, and ask the imaging center to follow the latest manufacturer MRI guidelines for your exact system.²¹ Does Medtronic DBS history matter, or is it questionable? Sometimes having the DBS history helps people feel comfortable. United States FDA summaries note that Medtronic’s DBS systems have approvals dating back to 1997 for movement disorders, with later expansions and newer platforms over time.¹¹˒²³ This doesn't mean that “older is better” or “newer is better,” but it helps explain why different clinics and patients talk about different device names. How do device options differ outside the US? DBS model names, MRI labeling details, and what is marketed can differ by country and region, even when the manufacturer is the same. If you live outside the US or receive care in more than one country, ask your medical team to confirm which Medtronic systems are available where you live.²˒³˒²¹

Outside of the United States, deep brain stimulation (DBS) has found support by a growing mix of manufacturers and research programs, and what is available is going to depend on your specific country’s regulatory pathway, your medical clinic’s training, and local follow-up resources. For instance, in Europe, devices are typically brought to market through CE marking under EU (European Union) medical device rules, while Japan and China use national regulators such as PMDA and NMPA, which means that the same DBS feature may be fully available in one region and still considered investigational in another. At the same time, global DBS research is moving toward more personalized therapy, including directional leads that help shape stimulation, new sensing systems that record certain brain signals, adaptive or closed-loop DBS that can adjust stimulation based on those signals, and special remote programming for some DBS settings.⁵ ⁶ ⁷ Think of this section of the FAQ as a map through an ever moving science that hopefully will help you understand who is building DBS systems outside the US, what “approval” means in different places, and which research directions are real, promising, and worth discussing with your care team. Let's get started! What do we mean by “Non-US DBS manufacturers”? “Non-US DBS manufacturers” are companies that develop and sell deep brain stimulation (DBS) systems primarily outside the United States and it's FDA governance agency. DBS itself is an implanted system that delivers electrical stimulation to specific brain targets, and it is adjusted over time by a specialized clinical team.¹ Why do DBS device options look different outside the United States? Because each geographic region can have its own medical device rules, and “approved for use” can mean different things in different places, there are really great examples to share with you: • European Union: devices generally need CE marking to be placed on the market, after conformity assessment under EU rules, and manufacturers carry major responsibility for demonstrating compliance.² ³ • Japan: certain medical devices require approval by Japan’s Ministry of Health, Labour and Welfare (MHLW), with review of safety and effectiveness by the Pharmaceuticals and Medical Devices Agency (PMDA).⁴ ⁵ • China: devices are reviewed and regulated by the National Medical Products Administration (NMPA), which posts announcements about innovative device approvals.⁶ Now, “available” isn't just about the technology, it is about your country’s approvals, the training for your clinic as well as their support, and finally what the follow-up medical care infrastructure looks like for you locally.² ⁴ ⁶ Which non-US DBS manufacturers are commonly discussed in published sources? Below are some examples that we've been able to collect that have appeared in manufacturer materials and peer-reviewed studies and regulatory sources. This is NOT a complete list, and remember that the “best” system is always going to be a system that is individual to you! • Newronika (Italy), AlphaDBS: Newronika reports their AlphaDBS as an adaptive DBS system, that means that stimulation can be adjusted in response to sensed signals from your brain, rather than haveing a constant signal of stimulation.⁷ Independent industry reporting has described that there is CE Mark approval for AlphaDBS for Parkinson’s disease in Europe in 2025.⁸ • Aleva Neurotherapeutics (Switzerland), directSTIM: Aleva reports CE marking for its directSTIM DBS system, describing that their directional lead design is intended to shape stimulation more even more precisely than most other DBS systems.⁹ ¹⁰ Aleva has also reported to the United States FDA approval for an Investigational Device Exemption (IDE) study, which is a research pathway, meaning that it is approved by the FDA for research solely, wich is not the same as broad commercial availability in the US.¹¹ • PINS Medical (China): China’s NMPA has announced approval in 2024 for multiple PINS DBS components, including DBS electrode leads and dual-channel pulse generators, with both being rechargeable batteries.⁶ Academic publications we found describe DBS care workflows in China using these PINS devices, including remote programming models in some settings.¹² • SceneRay (China): A widely cited tech review describes the SceneRay as a Chinese DBS company that has features such as remote wireless programming in earlier generations of its DBS platform.¹³ There is little known about the SceneRay at the time we were writing this, but as with all things in China, often information is hard to find. It is important to know that even when a manufacturer exists in a non-United States region, specific models, MRI conditions, remote features, and approved indications can vary by country and by device generation. If you live outside of the United States, we recommend that you confirm with your medical team about using the exact implanted model name and the most current device manual in your location.² ³ Are non-US DBS systems “better” or “worse” than US systems? Not necessarily, as DBS system outcomes can be dependent on so many moving parts, which can include: • Careful surgical targeting and lead placement¹ • Ongoing programming skill and follow-up access¹ • Device features that match your needs, such as directional leads or sensing, when appropriate¹ ⁷ ¹³ A helpful way to frame it is to compare the DBS systems by “fit,” meaning fit for your symptoms, your lifestyle, and your local medical team’s experience, rather than chasing the latest and greatest features in DBS technology.¹ What is “CE Mark,” in plain language, and why do people mention it with DBS devices? In everyday terms, CE marking is how many medical devices are legally placed on the market in the European Economic Area, after conformity assessment under EU rules.² ³ The European Commission notes manufacturers will take primary and ultimate responsibility for getting devices CE-marked for the European market.² If you are reading news articles about a DBS system's “CE Mark approval,” consider the following: • Does this CE-marked DBS system apply to my condition and in my country? • Which exact model and leads are included in the approval? • What follow-up, programming tools, and MRI conditions apply to that exact configuration?² ³ What does “PMDA” mean for DBS device availability in Japan? PMDA is Japan’s regulatory agency that reviews medical products for quality, safety, and efficacy from a scientific perspective, and for some devices, PMDA review supports MHLW (Japan's Ministry of Health, Labour and Welfare) approval decisions.⁴ ⁵ If you live in Japan, the most reliable way to understand your DBS options is through your implant/medical center, paired with PMDA and manufacturer documentation for your exact model.⁴ What DBS research is happening globally right now? This is the exciting part of DBS systems! What is cooking in the kitchen! DBS research is truly active worldwide, and most research questions are focusing on making therapy more personalized, more treatable conditions, more precise programming, and DBS systems that are easier to maintain over time. Let's look at some major research directions as found in the year 2025: • Adaptive DBS and closed-loop DBS: Adaptive DBS, sometimes called closed-loop DBS, uses signals to adjust your stimulation dynamically rather than delivering constant stimulation, or having to manually adjust the programming voltage, frequency and bandwidth.⁷ ¹⁴ Some reviews describe that there is a rapid growth in "biomarker" detection, in control strategies, and in data-driven approaches. This includes certain AI methods that help to decode your motor movement from signals it receives.¹⁴ Some published materials also describe that some structured programming steps and sensing methods actively being studied in ongoing trials.¹⁵ • Better sensing and signal processing: One of the biggest questions to resolve in DBS neurostimulation is removing stimulation artifact and delivering low-latency feedback, which are essential for many closed-loop designs.¹⁶ So, if they can minimize the latency (the time it take for the therapy to be delivered to the target region of the brain) this will help with this closed-loop therapy, being faster and seeing quicker results in treatment. • Remote DBS care and “tele-programming”: Some medical research centers, especially in large geographic regions, have been studying remote programming models to support follow-up care. A peer-reviewed report has described a remote programming experience in China that uses PINS devices, which are medical devices that use a "plug" with pins that provided faster delivery of information.¹² Some reviews also discuss remote programming capabilities in certain non-US DBS platforms.¹³ • New indications and new targets: Global research continues in psychiatric and behavioral indications, and other neurological conditions. These are super complex areas, and many uses remain investigational, meaning they are studied in trials and are not universally approved or available.¹ ¹⁴ If the condition is severe enough, the patient can sometimes get buy-in to try DBS for it's therapeutic value. But, how can you track DBS research without getting lost in all of the gossip and hype? There are three basic "anchors" we recommend you using: • Anchor 1: Is it approved where I live? Approval is traditionally country-specific, and the same device or feature may be approved in one region and investigational in another.² ⁴ ⁶ • Anchor 2: Is it studied in a registered clinical trial? ClinicalTrials.gov (ClinicalTrials.gov)is a great place to see registered studies, including some closed-loop DBS studies.¹⁷ • Anchor 3: Is there peer-reviewed evidence that matches my condition? Look for review articles and trial publications, and bring your questions to your DBS team for interpretation in the context of your health.¹ ¹⁴ ¹⁵ What questions should I ask my clinician if I am considering DBS outside the US, or moving internationally with DBS? Here are some questions that can help you when having conversations with your medical team about what is right for you: Device and approvals • Which exact DBS model, lead model, and battery type do I have, and what are the official manuals for my country? • Is my system approved, supported, and serviceable where I am moving?² ⁴ Follow-up and programming • Who will program my device locally, and what is the plan if I need urgent adjustments? • Are remote visits available in this region, and if so, what can be done remotely versus in-person?¹² ¹³ MRI and procedures • What are the MRI conditions for my exact device configuration, in my new country’s system? • Which procedures should I always flag before I receive care?¹ Practical continuity • What records should I carry, and what information does a new clinic need to take over safely?¹ What should I do if I read about a new DBS system online and want to know if it applies to me? A simple, empowering next step is to bring a short “fact packet” to your next visit that can include the following: • The device name and model • The region mentioned (EU, Japan, China, other) • The claim being made (directional lead, remote programming, adaptive DBS) Then ask your medical team: • “Is this available or relevant in my country and for my diagnosis?” • “If not, is there a trial pathway, and what would eligibility look like?” • “What do you think are the real-world pros and cons for someone like me?”¹ ² ⁴

Abbott Sources: • National Institute of Neurological Disorders and Stroke. Deep Brain Stimulation (DBS). Updated August 1, 2025. Accessed December 28, 2025. https://www.ninds.nih.gov/health-information/disorders/deep-brain-stimulation-dbs (https://www.ninds.nih.gov/health-information/disorders/deep-brain-stimulation-dbs?utm_source=chatgpt.com) • Mayo Clinic. Deep brain stimulation. Updated September 19, 2023. Accessed December 28, 2025. https://www.mayoclinic.org/tests-procedures/deep-brain-stimulation/about/pac-20384562 (https://www.mayoclinic.org/tests-procedures/deep-brain-stimulation/about/pac-20384562?utm_source=chatgpt.com) • Parkinson’s Foundation. Deep Brain Stimulation (DBS). Accessed December 28, 2025. https://www.parkinson.org/living-with-parkinsons/treatment/surgical-treatment-options/deep-brain-stimulation (https://www.parkinson.org/living-with-parkinsons/treatment/surgical-treatment-options/deep-brain-stimulation?utm_source=chatgpt.com) • US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Abbott Infinity DBS System, PMA P140009/S039. January 2, 2020. Accessed December 28, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140009S039B.pdf (https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140009S039B.pdf?utm_source=chatgpt.com) • US Food and Drug Administration. Premarket Approval (PMA): P140009/S039. Page last updated December 22, 2025. Accessed December 28, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140009S039 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140009S039&utm_source=chatgpt.com) • The Michael J. Fox Foundation for Parkinson’s Research. FDA Approves New Deep Brain Stimulation Device. June 16, 2015. Accessed December 28, 2025. https://www.michaeljfox.org/news/fda-approves-new-deep-brain-stimulation-device (https://www.michaeljfox.org/news/fda-approves-new-deep-brain-stimulation-device?utm_source=chatgpt.com) • Abbott Neuromodulation. DBS Therapy for Parkinson’s Disease (HCP). Accessed December 28, 2025. https://www.neuromodulation.abbott/us/en/healthcare-professionals/parkinsons.html (https://www.neuromodulation.abbott/us/en/healthcare-professionals/parkinsons.html?utm_source=chatgpt.com) • Abbott. Clinician’s Manual (Infinity DBS System lead and system details). Published 2024. Accessed December 28, 2025. https://manuals.eifu.abbott/content/dam/av/manuals-eifu/global/AT/en/ARTEN600237278_A.pdf (https://manuals.eifu.abbott/content/dam/av/manuals-eifu/global/AT/en/ARTEN600237278_A.pdf?utm_source=chatgpt.com) • Abbott. Abbott Receives Expanded Indication From the U.S. FDA for Directional Deep Brain Stimulation System to Treat Parkinson’s Disease. January 24, 2020. Accessed December 28, 2025. https://abbott.mediaroom.com/2020-01-24-Abbott-Receives-Expanded-Indication-From-the-U-S-FDA-for-Directional-Deep-Brain-Stimulation-System-to-Treat-Parkinsons-Disease (https://abbott.mediaroom.com/2020-01-24-Abbott-Receives-Expanded-Indication-From-the-U-S-FDA-for-Directional-Deep-Brain-Stimulation-System-to-Treat-Parkinsons-Disease?utm_source=chatgpt.com) • Abbott. Abbott Introduces NeuroSphere Virtual Clinic, First-of-its-Kind Remote Neuromodulation Patient-Care Technology in the U.S. March 8, 2021. Accessed December 28, 2025. https://abbott.mediaroom.com/2021-03-08-Abbott-Introduces-NeuroSphere-TM-Virtual-Clinic-First-of-its-Kind-Remote-Neuromodulation-Patient-Care-Technology-in-the-U-S (https://abbott.mediaroom.com/2021-03-08-Abbott-Introduces-NeuroSphere-TM-Virtual-Clinic-First-of-its-Kind-Remote-Neuromodulation-Patient-Care-Technology-in-the-U-S?utm_source=chatgpt.com) • American Parkinson Disease Association. New technology from Abbott allows for remote programming of DBS device. March 19, 2021. Accessed December 28, 2025. https://www.apdaparkinson.org/article/new-technology-from-abbott-allows-for-remote-programming-of-dbs-device/ (https://www.apdaparkinson.org/article/new-technology-from-abbott-allows-for-remote-programming-of-dbs-device/?utm_source=chatgpt.com) • Esper CD, et al. Necessity and feasibility of remote tele-programming for deep brain stimulation. J Neurol. 2022. Accessed December 28, 2025. https://www.sciencedirect.com/science/article/pii/S1353802022000256 (https://www.sciencedirect.com/science/article/pii/S1353802022000256?utm_source=chatgpt.com) • Abbott Neuromodulation. MRI Support, DBS Full Systems (Infinity DBS). Accessed December 28, 2025. https://www.neuromodulation.abbott/us/en/healthcare-professionals/mri-support/mri-dbs-full-systems.html (https://www.neuromodulation.abbott/us/en/healthcare-professionals/mri-support/mri-dbs-full-systems.html?utm_source=chatgpt.com) • US Food and Drug Administration. Medical Device Recall: St. Jude Medical Infinity DBS System (Class 2). Accessed December 28, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=168771 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=168771&utm_source=chatgpt.com) • Abbott Neuromodulation. DBS Patient Controller App User’s Guide. Published 2023. Accessed December 28, 2025. https://www.neuromodulation.abbott/content/dam/nm/neuromodulation/downloadables/23-77762_DBS_PC_App_GD_r4b_FNL_DIGITAL.pdf (https://www.neuromodulation.abbott/content/dam/nm/neuromodulation/downloadables/23-77762_DBS_PC_App_GD_r4b_FNL_DIGITAL.pdf?utm_source=chatgpt.com) • Apple App Store. Patient Controller NR, US. Accessed December 28, 2025. https://apps.apple.com/us/app/patient-controller-nr-us/id1059237634 (https://apps.apple.com/us/app/patient-controller-nr-us/id1059237634?utm_source=chatgpt.com) • US Food and Drug Administration. Infinity DBS System Clinician’s Manual (labeling), PMA P140009/S039D. 2020. Accessed December 28, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140009S039D.pdf (https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140009S039D.pdf?utm_source=chatgpt.com) • Hartford HealthCare. New, App-Controlled Deep Brain Stimulation Technology. February 12, 2018. Accessed December 28, 2025. https://hartfordhospital.org/about-hh/news-center/news-detail?articleId=12573&publicid=461(https://hartfordhospital.org/about-hh/news-center/news-detail?articleId=12573&publicid=461&utm_source=chatgpt.com) Boston Scientific Sources: • National Institute of Neurological Disorders and Stroke. Deep Brain Stimulation (DBS). Updated August 1, 2025. Accessed December 28, 2025. https://www.ninds.nih.gov/health-information/disorders/deep-brain-stimulation-dbs (https://www.ninds.nih.gov/health-information/disorders/deep-brain-stimulation-dbs?utm_source=chatgpt.com) • Mayo Clinic. Deep brain stimulation. Updated September 19, 2023. Accessed December 28, 2025. https://www.mayoclinic.org/tests-procedures/deep-brain-stimulation/about/pac-20384562 (https://www.mayoclinic.org/tests-procedures/deep-brain-stimulation/about/pac-20384562?utm_source=chatgpt.com) • US Food and Drug Administration. Vercise Deep Brain Stimulation Systems for Parkinson’s Disease: Labeling, PMA P150031/S040. Accessed December 28, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150031S040D.pdf(https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150031S040D.pdf?utm_source=chatgpt.com) • Boston Scientific. ImageReady MR Conditional Deep Brain Stimulation Systems. Accessed December 28, 2025. https://www.bostonscientific.com/imageready/en-US/dbs-system.html (https://www.bostonscientific.com/imageready/en-US/dbs-system.html?utm_source=chatgpt.com) • Boston Scientific. Vercise Indications, Safety and Warnings (EU site, regional differences). Accessed December 28, 2025. https://www.bostonscientific.com/en-EU/health-conditions/parkinson-s-disease/Vercise_Indications-Safety-and-Warnings.html (https://www.bostonscientific.com/en-EU/health-conditions/parkinson-s-disease/Vercise_Indications-Safety-and-Warnings.html?utm_source=chatgpt.com) • US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): PMA P150031/S064. Accessed December 28, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150031S064B.pdf (https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150031S064B.pdf?utm_source=chatgpt.com) • US Food and Drug Administration. Premarket Approval (PMA): P150031, Vercise DBS System. Accessed December 28, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P150031 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P150031&utm_source=chatgpt.com) • Boston Scientific. Vercise Genus Batteries. Accessed December 28, 2025. https://www.bostonscientific.com/en-US/medical-specialties/neurological-surgery/deep-brain-stimulation-system/vercise-genus-batteries.html (https://www.bostonscientific.com/en-US/medical-specialties/neurological-surgery/deep-brain-stimulation-system/vercise-genus-batteries.html?utm_source=chatgpt.com) • Practical Neurology. FDA Approves a Deep Brain Stimulation System for Parkinson’s as Safe for MRI. August 23, 2019. Accessed December 28, 2025. https://practicalneurology.com/news/fda-approves-a-deep-brain-stimulation-system-for-parkinsons-as-safe-for-mri/2468999/ (https://practicalneurology.com/news/fda-approves-a-deep-brain-stimulation-system-for-parkinsons-as-safe-for-mri/2468999/?utm_source=chatgpt.com) • Boston Scientific. Vercise Genus DBS Leads (Cartesia directional lead overview, regional product page). Accessed December 28, 2025. https://www.bostonscientific.com/en-EU/products/deep-brain-stimulation-systems/vercise-genus-dbs/leads.html (https://www.bostonscientific.com/en-EU/products/deep-brain-stimulation-systems/vercise-genus-dbs/leads.html?utm_source=chatgpt.com) • Boston Scientific. Vercise DBS System (MICC and system overview). Accessed December 28, 2025. https://www.bostonscientific.com/en-US/products/deep-brain-stimulation-systems/vercise-tm-dbs.html (https://www.bostonscientific.com/en-US/products/deep-brain-stimulation-systems/vercise-tm-dbs.html?utm_source=chatgpt.com) • Boston Scientific. Deep Brain Stimulation (DBS) FAQ (MRI access note). Accessed December 28, 2025. https://www.dbsandme.com/en/support-and-resources/faq.html (https://www.dbsandme.com/en/support-and-resources/faq.html?utm_source=chatgpt.com) • Boston Scientific. ImageReady MRI Guidelines for DBS Systems (device-specific conditions). Accessed December 28, 2025. https://www.bostonscientific.com/content/dam/elabeling/nm/92438760-11_Rev_A_Image_R_MRI_Guide_DBS_IFU_MRI_INF_EN_s.pdf(https://www.bostonscientific.com/content/dam/elabeling/nm/92438760-11_Rev_A_Image_R_MRI_Guide_DBS_IFU_MRI_INF_EN_s.pdf?utm_source=chatgpt.com) Medtronic Sources: • National Institute of Neurological Disorders and Stroke. Deep Brain Stimulation (DBS). Updated August 1, 2025. Accessed December 28, 2025. https://www.ninds.nih.gov/health-information/disorders/deep-brain-stimulation-dbs (https://www.ninds.nih.gov/health-information/disorders/deep-brain-stimulation-dbs?utm_source=chatgpt.com) • Medtronic. Percept PC neurostimulator with BrainSense technology (healthcare professionals). Accessed December 28, 2025. https://www.medtronic.com/en-us/healthcare-professionals/products/neurological/deep-brain-stimulation/electrical-stimulation-systems/percept-pc-neurostimulator.html (https://www.medtronic.com/en-us/healthcare-professionals/products/neurological/deep-brain-stimulation/electrical-stimulation-systems/percept-pc-neurostimulator.html?utm_source=chatgpt.com) • Medtronic. Percept RC neurostimulator with BrainSense technology (healthcare professionals). Accessed December 28, 2025. https://www.medtronic.com/en-us/healthcare-professionals/products/neurological/deep-brain-stimulation/electrical-stimulation-systems/percept-rc-neurostimulator.html (https://www.medtronic.com/en-us/healthcare-professionals/products/neurological/deep-brain-stimulation/electrical-stimulation-systems/percept-rc-neurostimulator.html?utm_source=chatgpt.com) • Medtronic. Activa PC neurostimulator (healthcare professionals, Sweden site). Accessed December 28, 2025. https://www.medtronic.com/se-sv/healthcare-professionals/products/neurological/deep-brain-stimulation-systems/activa-pc.html (https://www.medtronic.com/se-sv/healthcare-professionals/products/neurological/deep-brain-stimulation-systems/activa-pc.html?utm_source=chatgpt.com) • Medtronic. Activa RC neurostimulator (healthcare professionals). Accessed December 28, 2025. https://www.medtronic.com/en-us/healthcare-professionals/products/neurological/deep-brain-stimulation/electrical-stimulation-systems/activa-rc-neurostimulator.html (https://www.medtronic.com/en-us/healthcare-professionals/products/neurological/deep-brain-stimulation/electrical-stimulation-systems/activa-rc-neurostimulator.html?utm_source=chatgpt.com) • Medtronic. FDA Approves First-of-its-Kind SenSight Directional Lead System for DBS Therapy. June 7, 2021. Accessed December 28, 2025. https://news.medtronic.com/2021-06-07-FDA-Approves-First-of-its-Kind-SenSight-TM-Directional-Lead-System-for-DBS-Therapy (https://news.medtronic.com/2021-06-07-FDA-Approves-First-of-its-Kind-SenSight-TM-Directional-Lead-System-for-DBS-Therapy?utm_source=chatgpt.com) • Medtronic. SenSight directional lead (healthcare professionals). Accessed December 28, 2025. https://www.medtronic.com/en-us/healthcare-professionals/products/neurological/deep-brain-stimulation/dbs-therapy-leads/sensight-directional-lead.html (https://www.medtronic.com/en-us/healthcare-professionals/products/neurological/deep-brain-stimulation/dbs-therapy-leads/sensight-directional-lead.html?utm_source=chatgpt.com) • US Food and Drug Administration. Premarket Approval (PMA) P960009/S007: Indications for Parkinson’s disease (GPi or STN). Accessed December 28, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S007 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S007&utm_source=chatgpt.com) • US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED) P960009/S478B: Activa, Percept and SenSight DBS Therapy System; includes Parkinson’s indications and adaptive DBS feature. February 20, 2025. Accessed December 28, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf (https://www.accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf?utm_source=chatgpt.com) • US Food and Drug Administration. Premarket Approval (PMA) P960009/S051: Indications for essential tremor or parkinsonian tremor. Accessed December 28, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P960009S051 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P960009S051&utm_source=chatgpt.com) • US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED) P960009/S478B: prior approvals include 1997 VIM thalamic stimulation for tremor. February 20, 2025. Accessed December 28, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf (https://www.accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf?utm_source=chatgpt.com) • Medtronic. Medtronic Receives FDA Approval for Deep Brain Stimulation Therapy for Medically Refractory Epilepsy. May 1, 2018. Accessed December 28, 2025. https://news.medtronic.com/2018-05-01-Medtronic-Receives-FDA-Approval-for-Deep-Brain-Stimulation-Therapy-for-Medically-Refractory-Epilepsy (https://news.medtronic.com/2018-05-01-Medtronic-Receives-FDA-Approval-for-Deep-Brain-Stimulation-Therapy-for-Medically-Refractory-Epilepsy?utm_source=chatgpt.com) • US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED) P960009/S219B: Medtronic DBS System for Epilepsy (Activa PC platform) and components. April 27, 2018. Accessed December 28, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf/P960009S219b.pdf (https://www.accessdata.fda.gov/cdrh_docs/pdf/P960009S219b.pdf?utm_source=chatgpt.com) • US Food and Drug Administration. Medtronic Activa Dystonia Therapy. November 7, 2023. Accessed December 28, 2025. https://www.fda.gov/media/187187/download?attachment= (https://www.fda.gov/media/187187/download?attachment&utm_source=chatgpt.com) • US Food and Drug Administration. Humanitarian Device Exemption (HDE): Reclaim DBS Therapy for Obsessive Compulsive Disorder (OCD), H050003. Accessed December 28, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375533 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375533&utm_source=chatgpt.com) • US Food and Drug Administration. Humanitarian Device Exemption (HDE). January 13, 2025. Accessed December 28, 2025. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption (https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption?utm_source=chatgpt.com) • US Food and Drug Administration. Clinician Programmer Application for Deep Brain Stimulation P960009/S478C: describes local field potential signal capture in Percept systems. February 14, 2025. 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