Storage environment. High stimulation outputs. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. Scuba diving or hyperbaric chambers. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. Electrical medical treatment. Make the Bold Choice Getting an MRI | Medtronic High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Read this section to gather important prescription and safety information. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. Therapeutic radiation. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. The implanted components of this neurostimulation system are intended for a single use only. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Removing components. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. This equipment is not serviceable by the customer. Conditional 5. The Eterna SCS 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. 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. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Product materials. Security, antitheft, and radiofrequency identification (RFID) devices. Wireless use restrictions. High stimulation outputs. 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. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. If patients feel that the TENS device may be interfering with the neurostimulator, patients should discontinue using the TENS device until they talk with their physician. Programmer and controller devices are not waterproof. 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. High-output ultrasonics and lithotripsy. Use caution when sedating the patient. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. Do not use the application if the operating system is compromised (that is, jailbroken). Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). Lead insertion through sheath. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Excessive lead migration may require reoperation to replace the leads. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Implanted cardiac systems. If two systems are implanted, ensure that at least 20 cm (8 in.) Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. FDA approves new MRI compatibility for Abbott's Proclaim spinal cord Use care when reinserting a stylet. (2) The method of its application or use. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Lasting Relief through our smallest system yet. Use extreme care when handling system components. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Long-term safety and effectiveness. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). FDA Expands MRI Compatibility With Spinal Stimulation for Pain MRI Support | Abbott Operation of machinery and equipment. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. 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). Do not use excessive pressure when injecting through the sheath. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Store components and their packaging where they will not come in contact with liquids of any kind. The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 Using surgical instruments. Pregnancy and nursing. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). separates the implanted IPGs to minimize unintended interaction with other system components. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. To prevent unintended stimulation, do not modify the operating system in any way. Before reinserting the sheath, verify there is no damage to the sheath. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). 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. Devices with one-hour recharge per day. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Patients should cautiously approach such devices and should request help to bypass them. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Lead movement. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. Always perform removal of implanted components with the patient conscious and able to give feedback. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. Set the electrosurgery device to the lowest possible energy setting. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Electromagnetic interference (EMI). Neurostimulation should not be used on patients who are poor surgical candidates. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. ABBOTT PARK, Ill., Jan. 26, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. Damage to the system may not be immediately detectable. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Skydiving, skiing, or hiking in the mountains. 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). 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your generator immediately.). Failure to do so may result in damage to the sheath. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Exit Surgery mode during intraoperative testing and after the procedure is completed. Wireless use restrictions. 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). Component handling. 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. 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, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. External defibrillators. Lead handling. The system is intended to be used with leads and associated extensions that are compatible with the system. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. High-output ultrasonics and lithotripsy. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Store components and their packaging where they will not come in contact with liquids of any kind. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Care and handling of components. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Keep programmers and controllers dry. If needed, return the equipment to Abbott Medical for service. Follow proper infection control procedures. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. Avoid excessive stimulation. Infection. 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. Unwanted changes in stimulation may include a jolting or shocking feeling. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Ensure the patients neurostimulation system is in MRI mode. If interference occurs, try holding the phone to the other ear or turning off the phone. Failure to do so may cause harm to the patient such as damage to the dura. Implantation of multiple leads. The system is intended to be used with leads and associated extensions that are compatible with the system. Storage environment. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. 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. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. ), 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 or breakage, Stimulation in unwanted places (such as stimulation of the chest wall), 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, sensory loss, or pain below the level of the implant, Pain or bleeding where the needle was inserted, Seroma (mass or swelling) at the implant site, Allergic or rejection response to device or implant materials, Hardware malfunction that requires replacing the neurostimulator, Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain, Formation of reactive tissue in the epidural space around the lead, which can cause delayed spinal cord compression and paralysis and requires surgical intervention (Time to onset can range 23 from weeks to many years after implant.). Neuromodulation. 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 atmedical.abbott/manuals). A summary of the safety and clinical performance (SSCP) for these devices will be published at https://ec.europa.eu/tools/eudamed by the Notified Bodies in accordance with the requirements of EU MDR 2017/745 and associated timelines. Securing the IPG. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Activities requiring excessive twisting or stretching. Always perform removal with the patient conscious and able to give feedback. 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. Implant heating. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinsons disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI. Failure to provide strain relief may result in lead migration requiring a revision procedure. radiofrequency identification (RFID) devices. Household appliances. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Needle insertion. Confirm implant locations and scan requirements for the patients system. Free from the hassles of recharging. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. INDICATIONS FOR USE Read this section to gather important prescription and safety information. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. 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. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Activities requiring coordination. IPG disposal. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Mobile phones. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. 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. commercial electrical equipment (such as arc welders and induction furnaces). 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. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Output power below 80 W is recommended for all activations. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. 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. 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. Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. Explosive and flammable gasses. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Operation of machines, equipment, and vehicles. 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. After defibrillation, confirm the neurostimulation system is still working. Battery care. Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. 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. If lithotripsy must be used, do not focus the energy near the IPG. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Sheath insertion precaution. Sheath insertion warning. The following warnings apply to this neurostimulation system. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Control of the patient controller. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S. - New U.S. FDA-approved labeling lifts restrictions on 60-centimeter Octrode leads,. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. For more information, see the clinician programmer manual. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. 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. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. 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. Clinician training. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) January 4, 2022 By Sean Whooley. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Set the electrosurgery device to the lowest possible energy setting. Ultrasonic scanning equipment. A recharge-by date is printed on the packaging. Abbott's Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the . Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. away from the generator and avoid placing any smart device in a pocket near the generator. MRI Support | Abbott Neuromodulation Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. If lithotripsy must be used, do not focus the energy near the IPG.
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