NEUROMODULATION
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TECHNOLOGICAL
ADVANCES

PAVING THE WAY FOR SUCCESSFUL
CHRONIC PAIN OUTCOMES

MAKE A DIFFERENCE IN THE LIVES OF YOUR
CHRONIC PAIN PATIENTS

Whether your patients experience precise or pervasive* pain, Abbott can help maximize outcomes by tailoring relief to your patient’s needs. Our advanced approach to neurostimulation involves two superior and proven therapies**2-4:
Our proprietary dorsal root ganglion (DRG) therapy targets certain intractable focal pain of the lower limbs caused by complex regional pain syndrome (CRPS),2 while our spinal cord stimulation (SCS) therapy, with revolutionary BurstDR™ stimulation,*** helps relieve pain felt broadly in the back, arms and/or legs.

A MAJORITY OF PATIENTS SAY THEY PREFER BURSTDR™ STIMULATION WHEN COMPARED TO TRADITIONAL TONIC STIMULATION1,2

BurstDR™ stimulation, exclusively from Abbott, is a unique, proven technology3 that improves upon traditional neurostimulation therapy by treating the patient’s whole pain, both physically and emotionally.4,5

BurstDR simulation diagram

A SUPERIOR PAIN RELIEF OPTION4,5

Our BurstDR™ stimulation technology has been proven to provide superior pain relief from overall pain and a reduction in back and leg pain compared to traditional tonic neurostimulation therapies.

 

In addition to BurstDR stimulation, we’ve designed our neurostimulation systems with Invisible Therapy™, patient-friendly features to make our systems accessible and easy to use. Learn more about our Invisible Therapy™ >

THERAPY DESIGNED TO HELP YOUR PATIENTS FOCUS ON THEIR LIFE, NOT THEIR PAIN

Traditional neurostimulation has been used safely for decades, but it doesn't always work for patientswith causalgia or complex regional pain syndrome (CRPS).8 Today, there’s a new, non-opioid solution called dorsal root ganglion, or DRG, stimulation that’s been proven to provide superior** relief for patients suffering from CRPS and other intense, lower-limb pain.8

DRG pain relief infographic


HOW DRG THERAPY IS DIFFERENT

Everyone has clusters of nerve cells along their spine called dorsal root ganglion, or DRG. Researchers have found that certain groups of DRG nerves correspond to specific areas of the body — such as the foot, knee, hip and groin — where people experience the pain.

By focusing electrical stimulation specifically on the DRG, we’re able to interrupt pain signals before they reach the brain and change them with an electrical pulse, so patients don’t feel pain in the same way and can get back to doing the things they love.

In addition to our innovations in DRG therapy, we’ve designed our neurostimulation systems with Invisible Therapy™, patient-friendly features to make our systems accessible and easy to use. Learn more about our Invisible Therapy™ >

When it comes to something as sacred as the body, your patients expect the very best that medical technology has to offer. That’s why Abbott has built its neurostimulation platform from the ground up with the patient experience in mind.


THE PREMIUM NEUROSTIMULATION PLATFORM

Our neurostimulation system platform exemplifies our philosophy behind Invisible Therapy™, letting your patients focus on their lives instead of their pain. Invisible Therapy™ features technologies that deliver an overall more patient- and doctor-friendly user experience:

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A LONGER-LASTING, RECHARGE-FREE DEVICE††

Potentially reducing the number of necessary procedures and replacement devices.

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PATIENT-FRIENDLY, EASY TO USE

Featuring familiar Bluetooth® wireless technology connectivity and Apple‡ mobile digital device compatibility.

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UPGRADEABLE TECHNOLOGY

Letting your patients benefit from the next advancements in chronic pain therapy without interruption or surgery.

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MR-CONDITIONAL LABELING

Many of our devices are MR conditional within certain parameters, enabling your patients to undergo an MRI scan with their implanted device.

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FEWER RESTRICTIONS ON DEVICE IMPLANT DEPTH††

Giving your patients the most comfortable experience with their implanted device.

SCS FOR CHRONIC PAIN

Abbott’s advanced spinal column stimulation (SCS) systems are designed to maximize patient outcomes. Learn more about our latest innovations in SCS technology.

 

*Pain that is broadly felt in a large area of the body.

**When compared to traditional tonic spinal cord stimulation based on outcomes from the ACCURATE IDE study.

***BurstDR™ stimulation, patented technology exclusively from Abbott, is also referred to as Burst stimulation in clinical literature.

†Based on new technologies available for DRG therapy.

†† When compared to the Axium™ Neurostimulator System.

‡ Indicates a third party trademark, which is property of its respective owner. Apple is a trademark of Apple, Inc. Bluetooth is a registered trademark of Bluetooth SIG, Inc.

 
REFERENCES
  1. St. Jude Medical. (2016). St. Jude Medical™ Proclaim™ Neurostimulation System Clinician’s Manual. Plano, TX. SUNBURST IDE study.
  2. St. Jude Medical. (2016). St. Jude Medical™ Prodigy™ Neurostimulation System Programming and Reference Manual. Plano, TX. SUNBURST IDE study.
  3. De Ridder, D., Vanneste, S., Plazier, M., Vancamp, T., (2015). Mimicking the Brain: Evaluation of St. Jude Medical’s Prodigy Chronic Pain System with Burst Technology. Expert Review of Medical Devices,12(2), 143–150.
  4. Proclaim™ Neurostimulation System Clinician’s Manual. Plano, TX. 2016.
  5. Prodigy™ Neurostimulation System Programming and Reference Manual. Plano, TX. 2016.
  6. Van Havenbergh T., Vancamp T., Van Looy P., Vanneste S., De Ridder D. 2014. Spinal Cord Stimulation for the Treatment of Chronic Back Pain Patients: 500-Hz vs. 1000-Hz Burst Stimulation. Neuromodulation 2014; E-pub ahead of print. DOI:10.1111/ner.12252.
  7. Schu S., Slotty P.J., Bara G., von Knop M., Edgar D., Vesper J. 2014. A Prospective, Randomized, Double-blind, Placebo-controlled Study to Examine the Effectiveness of Burst Spinal Cord Stimulation Patterns for the Treatment of Failed Back Surgery Syndrome. Neuromodulation 2014; e-pub ahead of print. DOI: 10.1111/ner.12197.
  8. Deer, TR, Levy, RM, Kramer, J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017; 158(4): 669-681. doi: 10.1097/j.pain.0000000000000814 ACCURATE IDE STUDY, St. Jude Medical. (n = 152)
IMPORTANT SAFETY INFORMATION

Spinal Cord Stimulation

Prescription and Safety Information

Read this section to gather important prescription and safety information.

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 

This neurostimulation system is 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 and intractable low back and leg pain.

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 manuals.sjm.com). For more information about MR Conditional products, visit the Abbott product information page at neuromodulation.abbott.

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.

  • During implant procedures, if electrosurgery devices must be used, take the following actions:
  •  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.

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.

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.

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.

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.

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).

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.

Wireless use restrictions. In some environments, the use of wireless functions (e.g., 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.)

Mobile phones. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system.

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.

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.

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.

Device modification. The 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.

Hospital and Medical Environments

High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, 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.

Adverse Effects 

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

  •  Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.)
  • Stimulation in unwanted places (such as radicular stimulation of the chest wall)
  • Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
  • Persistent pain at the 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

SJM-NWEB-0818-0180

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