Patients should cautiously approach such devices and should request help to bypass them. Do not crush, puncture, or burn the generator because explosion or fire may result. MRI Support | Abbott 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. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. 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. 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. Clinicians should be familiar with deep brain stimulation therapy and be experienced in the diagnosis and treatment of the indication for which the deep brain stimulation components are being used. Inaccurate ECG results may lead to inappropriate treatment of the patient. Needle insertion. Sheath rotation. 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. (2) The method of its application or use. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. If two systems are implanted, ensure that at least 20 cm (8 in.) Pregnancy and nursing. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Return any suspect components to Abbott Medical for evaluation. 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. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. To prevent unintended stimulation, do not modify the operating system in any way. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Scuba diving or hyperbaric chambers. Pediatric use. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Security, antitheft, and radiofrequency identification (RFID) devices. 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. Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. 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. Battery precaution. Restricted areas. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. If unpleasant sensations occur, the IPG should be turned off immediately. Security, antitheft, and radiofrequency identification (RFID) devices. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Abbott - Spinal Cord Stimulation To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. MRI Support | Abbott Neuromodulation Surgical advice for removal. Sheath retraction. Postural changes. 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. If unpleasant sensations occur, the device should be turned off immediately. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Interference with other devices. During implant procedures, if electrosurgery devices must be used, take the following actions: Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. Poor surgical risks. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Why Proclaim XR SCS System - Abbott Changes in blood glucose levels in response to any adverse effect
Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Wireless use restrictions. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. The force of the instruments may damage the lead or stylet. Loss of coordination is a potential side effect of DBS therapy. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Securing the IPG. 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,. Conscious sedation during removal. Exposure to body fluids or saline. Product materials. Patient selection. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Devices with one-hour recharge per day. Operation of machines, equipment, and vehicles. Infections related to system implantation might require that the device be explanted. 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). 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). January 4, 2022 By Sean Whooley. separates the implanted generators to minimize unintended interaction with other system components. Patients should not use this neurostimulation system if they are pregnant or nursing. Abbott's Proclaim XR Spinal Cord Stimulation System Now - Insider Therapeutic magnets. 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. 737202011056 v5.0 | Item approved for U.S. use only. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Neuromodulation. If radiation therapy is required, the area over the implanted generator should be shielded with lead. 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. Securing the anchor. Interference with wireless equipment. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. IMAGINE A FUTURE - cloud.neuroemail.abbott.com In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Confirm implant locations and scan requirements for the patients system. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Damage to the system may not be immediately detectable. Case damage. Securing the lead with the lead stabilizer will mitigate this risk. 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. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Have the patient check the device for proper functioning, even if the device was turned off. 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). The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown. IPG placement. Implantation of two systems. Coagulopathies. 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). Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. 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. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. To find Shipping Material Packaging Waste information, select Healthcare Professionals. External defibrillators. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Failure to provide strain relief may result in lead migration requiring a revision procedure. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. 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). Electrosurgery. 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. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Infection. Radiofrequency or microwave ablation. Infection. If two systems are implanted, ensure that at least 20 cm (8 in.) For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. The effect of mobile phones on deep brain stimulation is unknown. 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. FDA Expands MRI Compatibility With Spinal Stimulation for Pain Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location. 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. The Proclaim XR SCS system can provide relief to . The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Operation of machines, equipment, and vehicles. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. 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. To prevent injury or damage to the system, do not modify the equipment. Electrosurgery. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. 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. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. IPG disposal. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. away from the generator and avoid placing any smart device in a pocket near the generator. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Device modification. Make the Bold Choice Explosive and flammable gasses. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. Surgeon training. Skydiving, skiing, or hiking in the mountains. 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. In rare cases, this can create a medical emergency. Place the neurostimulator in Surgery mode before using an electrosurgery device. 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. 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. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems.