Here's to Conquering

Your Health

Real solutions for people living with chronic pain,
Parkinson’s disease and essential tremor

elderly couple with coffee
elderly couple with coffee
elderly couple with coffee

Technology to help you move and feel better

Neurostimulation therapies from Abbott allow people living with chronic pain and movement disorders to move easier and feel better. Neurostimulation is a medication-free* technology that can help chronic pain patients get back to living their lives. It also can combat the symptoms of movement disorders for those living with Parkinson's disease or essential tremor so daily tasks aren't as difficult.

Explore the portfolio of neurostimulation therapies designed to relieve your symptoms, no matter which condition you’re living with.

FDA approved to treat pain caused by Diabetic Peripheral Neuropathy (DPN)

The rechargeable Eterna™ SCS System and the recharge-free Proclaim™ SCS Family are now approved to treat pain caused by DPN.

gradient

Chronic Pain

Chronic pain happens when pain persists, sometimes inexplicably, for six or more months or longer than would generally be expected for recovery to a specific disease, injury or surgery. It’s often the result of an illness or injury. The good news? There are options for managing your symptoms.

Parkinson’s Disease

Parkinson’s disease is a slow, progressive movement disorder that can affect nearly every aspect of your daily life. Learn about how Deep Brain Stimulation (DBS) can help manage Parkinson's disease symptoms so you can live your best life.

Essential Tremor

Essential tremor is a unique condition that causes shaking or rhythmic trembling in parts of the body. If you’re living with essential tremor, or care for someone who does, find the treatment you need to get back to enjoying life again with DBS.
 

Streamline therapy with
NeuroSphere™ Digital Care

Experience care that supports your health and fits your life. Abbott’s NeuroSphere™ Digital Care combines digital health tools and technology that help you manage your movement disorder or chronic pain therapy like never before.

NeuroSphere™ Digital Care includes NeuroSphere™ Virtual Clinic, which was named among the 100 Best Inventions of 2021 by Time Magazine.1 Unique advantages of the application include:

Control therapy with your smartphone

Manage your neuromodulation therapy settings from our Patient Controller app.†§ You can access the Patient Controller app from either your own personal Apple mobile device or an Apple iPhone provided by Abbott.

Attend follow-up doctor visits with NeuroSphere™ Virtual Clinic

Connect with your doctor using secure, in-app video chat for follow-up care and real time programming adjustments, without ever needing to leave the comfort of your own home.

How NeuroSphere™ Virtual Clinic works

ns gradient

Hear stories from people with neuromodulation therapies

Kim considered herself a “professional volunteer” in her retirement. Whether she was giving her time at the nursing home or church, playing golf, swimming, oil painting, or gardening, Kim was “constantly doing something.” But things changed for her in January 2003 when she felt an unusual pain in her back while playing golf. A former hospital administrator and nurse, Kim self-medicated at first until she realized what she felt was more than a minor pain. Though she knew it wasn’t possible, she says, “When I walked, it felt like things would fall apart.”

Chronic Pain Was Disrupting Kim’s Life

After a while, Kim found her mobility extremely limited to the extent that she could no longer do her usual tasks and activities. She found driving her car uncomfortable and relied instead on a wheelchair or four-wheel walker during outings. To make matters worse, she could sleep for no more than a few hours at a time at night. After several back surgeries, the pain she felt spread to her back and her lower buttocks and leg.

Running out of options, reluctant to have another surgery, and frustrated with taking pain medications, Kim talked with her family doctor who mentioned the possibility of using neurostimulation to manage her pain. Her doctor explained the possible benefits of neurostimulation as well as the risks. (Risks associated with the procedure and/or use of a neurostimulation system include infection, swelling, bruising, undesirable changes in stimulation, and the loss of strength or use in an affected limb or muscle group (e.g., paralysis). For a complete list of possible complications associated with neurostimulation, refer to the important safety information page and talk to your doctor.

After hearing about neurostimulation, she was immediately interested and told her doctor she was ready to have the surgery “tomorrow.”

Kim Found Freedom Again With Neurostimulation

Kim says that while it did take time to get used to having an implanted system, she was soon back to her busy schedule and doing things she hadn’t been able to do for years. She even asked her doctor if she could return to golf. He told her that certain activities can cause the leads to move, which can cause a reduction in pain relief. He also recommended that she give her body time to heal. Kim followed her doctor’s advice and waited six months before trying the sport. She says, “I can’t do everything I could before, but just being on a golf course has given me a sense of freedom from my pain.”

Kim wants people who suffer from chronic pain to know there is an alternative treatment available. “You don’t have to live with chronic pain. For me, neurostimulation is a better option than taking drugs. It’s worth a chance.”

Consult your doctor to discuss the risks and benefits of neurostimulation and determine if this therapy is right for you. The story above explains the experiences of an individual who has received a neurostimulation system to manage chronic pain of the trunk and/or limbs. These results with neurostimulation are specific to this individual. While most patients experience at least some reduction in pain, the amount of pain relief that individuals experience varies. The surgical placement and use of a neurostimulation system pose risks, the occurrence of which also varies by individual.

Find out if Abbott neurostimulation could be right for you

gradient

‡ Indicates a third party trademark, which is property of its respective owner.

* Follow your physician's guidance for your current medication regimen and do not make any changes to your medication usage without consulting with your health care provider.

† Available on eligible Apple mobile digital devices. For a list of personal Apple mobile digital devices compatible with Abbott’s Patient Controller app, visit http://www.NMmobiledevicesync.com/dbs OR http://www.NMmobiledevicesync.com/cp.

§ The app is available anywhere with a Wi-Fi connection and a sufficiently charged patient controller device.

 

1. Abrams A. The best inventions of 2021. Time. November 10, 2021. Accessed November 9, 2022. https://time.com/collection/best-inventions-2021/6113022/neurosphere-virtual-clinic/

Important Safety Information

Spinal Column Stimulation (SCS) Systems

Intended Use

This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system.

Indications For Use

Abbott Medical spinal cord stimulation (SCS) systems are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, nonsurgical back pain (without prior surgery and not a candidate for back surgery), and diabetic peripheral neuropathy of the lower extremities.

Contraindications

This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.

MRI Safety Information

Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. 

For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at medical.abbott/manuals). 

For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html

Warnings

The following warnings apply to this neurostimulation system.

Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.

Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients. 

Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient. 

Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.

Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 

Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure. 

  • Use bipolar electrosurgery only.

  • Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.

  • Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.

  • Set the electrosurgery device to the lowest possible energy setting.

  • Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket.

Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.

Other active implanted devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system.

Interference with other devices. Some of this system’s electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Avoid placing equipment components directly over other electronic devices. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected.

Operation of machines, equipment, and vehicles. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. However, current data shows that most patients using BurstDR™ stimulation therapy do not experience paresthesia. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment.

Explosive and flammable gasses. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The operation of these devices could cause them to ignite, causing severe burns, injury, or death.

Keep the device dry. Programmer and controller devices are not waterproof. Keep them dry to avoid damage. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing.

Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established.

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.

Use in patients with diabetes. Surgical complications and adverse effects may be more frequent and severe in patients with diabetes. The following additional considerations should be made for patients with diabetes:

  • A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) ≥8% (64 mmol/mol).
  • Monitor the patient’s blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes.
  • Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes.

Stimulation modes. The BurstDR™ stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population.

Device components. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient.

Device modification. Equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service.

Application modification. To prevent unintended stimulation, do not modify the operating system in any way. Do not use the application if the operating system is compromised (that is, jailbroken).

Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.

IPG disposal. Return all explanted IPGs to Abbott Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.

Product materials. Neurostimulation systems have materials that come in contact or may come in contact with tissue. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted.

Precautions

The following precautions apply to this neurostimulation system.

General Precautions
  • Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training.

  • Patient selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the neurostimulation system.

  • Infection. Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.

  • Implantation of two systems. If two systems are implanted, ensure that at least 20 cm (8 in.) separates the implanted IPGs to minimize unintended interaction with other system components.

  • Implantation of multiple leads. If multiple leads are implanted, leads and extensions should be routed in close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.
  • Implant healing. While charging the generator, patients may perceive an increase in temperature at the generator site. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation.
  • High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. If unpleasant sensations occur, the device should be turned off immediately.

  • Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).
  • Consumer goods and electronic devices. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator; however, it will not change the prescribed programmed parameters. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) away from the generator and avoid placing any smart device in a pocket near the generator. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support.
  • Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) six to eight weeks after implantation of a neurostimulation system. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation.
  • Patient training. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system.

  • Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient.

Sterilization and Storage
  • Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.

  • Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind.

Handling and Implementation
  • Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.
  • Recharge-by-date. A recharge‑by date is printed on the packaging. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation.
  • Handle the device with care. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.

  • Care and handling of components. Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.

  • Package or component damage. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to Abbott Medical for evaluation.

  • Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation.

  • System testing. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite.

Hospitals and Medical Environments
  • High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG.

  • Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.

  • External defibrillators. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established.

  • Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable.

Home and Occupational Environments
  • Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation.
    Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Patients should cautiously approach such devices and should request help to bypass them. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly.

  • Scuba diving or hyperbaric chambers. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician.

  • Wireless use restrictions. In some environments, the use of wireless functions (for example, Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)

Adverse Effects

In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: 

  • Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately

  • Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure

  • Stimulation in unwanted places (such as radicular stimulation of the chest wall) 

  • Lead migration, causing changes in stimulation or reduced pain relief 

  • Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space 

  • Cerebrospinal fluid (CSF) leakage 

  • Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant 

  • Persistent pain at the electrode or IPG site 

  • Seroma (mass or swelling) at the IPG site

  • Allergic or rejection response to implant materials 

  • Implant migration or skin erosion around the implant 

  • Battery failure

  • Changes in blood glucose levels in response to any adverse effect 

    NOTE: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate preoperative glycemic control. For adverse effects observed in the use of diabetic peripheral neuropathy, refer to the clinical summaries manual for SCS systems.

Safety And Effectiveness Studies

For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system.  

21 CR 801.109(b)  The label of the device, other than surgical instruments, bears:

(1) The symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, the blank to be filled with the word “physician,” “dentist,” “veterinarian,” or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and 

(2) The method of its application or use.

 

23-78280 MAT-2215216 v4.0 | Item approved for U.S. use only.

23-79001 MAT-2213926 v5.0 | Item approved for U.S. use only.