The system is intended to be used with leads and associated extensions that are compatible with the system. Patient's visual ability to read the patient controller screen. 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. 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, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. Cremation. Security, antitheft, and radiofrequency identification (RFID) devices. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Bathing. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. 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. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Implantation of two systems. This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. The Proclaim TM SCS System is also the first upgradeable and recharge-free spinal cord stimulation system capable of delivering both tonic stimulation and Abbott's proprietary BurstDR stimulation waveform, a superior therapy designed to more closely mimic how pain signals travel to the brain. For more information, see the clinician programmer manual. Infections related to system implantation might require that the device be explanted. Infections may require that the device be explanted. Neuromodulation. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Providing strain relief. Package or component damage. Output power below 80 W is recommended for all activations. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. If unpleasant sensations occur, the device should be turned off immediately. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Physicians should also discuss any risks of MRI with patients. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Operating the device near gas fumes or vapors could cause them to catch fire. The website that you have requested also may not be optimized for your screen size. Do not crush, puncture, or burn these devices because explosion or fire may result. If needed, return the equipment to Abbott Medical for service. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Failure to do so can damage or cut the lead or sheath. 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). 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. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Handle the device with care. Implantation of two systems. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Device modification. Approved models and implant locations for an MR Conditional lead-only system. Diathermy is further prohibited because it may also damage the neurostimulation system components. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Select patients appropriately for deep brain stimulation. 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. Advise patients about adverse effects. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Implant heating. 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. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. Damage to the system may not be immediately detectable. Diathermy therapy. High stimulation outputs. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Application modification. Device modification. Sheath insertion warning. Read this section to gather important prescription and safety information. 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. Do not suture directly onto the lead to avoid damaging the lead. Inaccurate ECG results may lead to inappropriate treatment of the patient. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Failure to do so may result in damage to the sheath. 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. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. External defibrillators. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. 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. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Patients should not use this neurostimulation system if they are pregnant or nursing. Do not use excessive pressure when injecting through the sheath. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. 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 programming of stimulation parameters exceeds the charge density limit of 30 C/cm2, a screen will appear warning you that the charge density is too high. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Operation of machines, equipment, and vehicles. Avoid placing equipment components directly over other electronic devices. Patient selection. Stabilizing the lead during insertion. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Exposure to body fluids or saline. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. The system is intended to be used with leads and associated extensions that are compatible with the system. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. 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 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. External defibrillators. Advancing components. Operation of machines, equipment, and vehicles. Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. Pediatric use. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. This may occur once the lead is in place and is connected to the neurostimulator and activated. 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. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Patients should be advised to not use therapeutic magnets. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Keep the device dry. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. The device should be turned off and the doctor contacted if this occurs. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in a severe injury or death. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Set the electrosurgery device to the lowest possible energy setting. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. Surgeon training. Free from the hassles of recharging. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. 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. Application modification. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. 737202011056 v5.0 | Item approved for U.S. use only. 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). Lead handling. Scuba diving or hyperbaric chambers. Other active implantable devices. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Preventing infection. Needle insertion. Equipment is not serviceable by the customer. 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. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Activities requiring excessive twisting or stretching. 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. For more information about MR Conditional deep brain stimulation (DBS) 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 DBS systems(available online atmedical.abbott/manuals). Therapeutic radiation. 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. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Infections related to system implantation might require that the device be explanted. Pain is not resolved. Poor surgical risks. Bending the sheath. Use care when reinserting a stylet. Operation of machines, equipment, and vehicles. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Security, antitheft, and radiofrequency identification (RFID) devices. Application modification. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Care and handling of components. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. 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,. Diathermy is further prohibited because it may also damage the neurostimulation system components. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Avoid programming either device in a unipolar mode (using the devices can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. Caution patients to not make unauthorized changes to physician-established stimulation parameters. 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), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Devices with one-hour recharge per day. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. 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. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. 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. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Neurosurgery Pain Management Orthopaedic Surgery 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Abandoned leads and replacement leads. Remove leads slowly. Generator disposal. Radiofrequency or microwave ablation. Unwanted changes in stimulation may include a jolting or shocking feeling. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. With the Proclaim XR SCS system, you can have hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings* without ever needing to charge the system. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. PDF View Shellock R & D Services, Inc. email: . Failure to provide strain relief may result in lead migration requiring a revision procedure. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). maximize the distance between the implanted systems; Use in patients with diabetes. 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. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Using the tunneling tool. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. The effect of mobile phones on deep brain stimulation is unknown. 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 . Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. 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. Overcommunicating with the IPG. Interference with wireless equipment. 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. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Removing each item in slow movements while holding the remaining components in place will assist this process. Pregnancy and nursing. 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). New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. 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. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. The tip of the sheath may whip around and could cause harm to the patient. Confirm implant locations and scan requirements for the patients system.