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*** Up to 10 years of battery longevity at the lowest dose setting: 0.6mA, 500 Ohms, duty cycle 30s on/360s off. Refer to the IFU for additional information. Safety comparisons and specific dose-response curves for each dosage have not been clinically established. NOTE: In neurostimulation therapy, ‘dose’ refers to the delivery of a quantity of energy to tissue. †† Up to 10 years of battery longevity at the lowest dose setting: 0.6mA, 500 Ohms, duty cycle 30s on/360s off. For a list of personal Apple ‡ mobile digital devices compatible with Abbott’s Patient Controller app, visit OR ‡‡ Available on eligible Apple ‡ mobile digital devices. ** Pain and suffering as measured by VAS. † Anywhere with a cellular or Wi-Fi ‡ connection and a sufficiently charged patient controller. * BurstDR™ stimulation superiority when compared to traditional tonic stimulation as studied in SUNBURST ® Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc. ‡ Indicates a third-party trademark, which is property of its respective owner. Be sure to talk to your doctor about the risks associated with the placement of a neurostimulation system. Complications such as infection, swelling, bruising and possibly the loss of strength in or use of an affected limb or muscle group (i.e., paralysis) are possible. Please note: The placement of the leads is a surgical procedure that exposes you to certain risks. If, at the end of the evaluation period, you and your doctor decide the Proclaim™ Plus or Proclaim™ XR SCS System is right for you, you can choose to have the system implanted. Improves your ability to perform daily activities.Your pain management doctor will determine if you are a candidate for stimulation therapy with the Proclaim™ Plus SCS System or Proclaim™ XR SCS System, and may recommend a temporary evaluation.ĭuring the temporary evaluation, you can see whether the therapy: Proclaim XR is currently under review for CE Mark.One of the advantages of the Proclaim™ Plus and Proclaim™ XR SCS Systems is that you can try them out to see how well they work for you before committing to an implanted system. Abbott is committed to developing life-changing solutions and putting the patient at the center of everything we do.” “This is a meaningful advancement for the millions of people who need new options when it comes to managing the effects of their chronic pain. Recharge-free means patients can live their lives without the constant reminder of being in treatment,” said Keith Boettiger, vice president of Abbott’s neuromodulation business. “Proclaim XR is the latest advancement in patient-centric pain therapy - opening the doors for people who don’t want to be burdened with the hassles of recharging. This means patients won’t need surgery to benefit from future advances in this technology.” “Proclaim XR is a major advancement in spinal cord stimulation and is an evidence-based therapy that is mobile app-based and features upgradeable software. Timothy Deer, president & CEO of The Spine and Nerve Center of the Virginias in Charleston, W.Va., in a news release. “For the 50 million people living with chronic pain in the United States, this is a new and exciting treatment that is supported with evidence validated by the BOLD study, an established protocol for titrated intermittent dosing to give patients individualized pain relief while using therapy for six hours or less per day,” said Dr. Data from this trial were presented at multiple medical society meetings, including the North American Neuromodulation Society (NANS) and the International Neuromodulation Society (INS) earlier this year. Even at the highest settings, the systems were still in use only 25% of the time, the company noted. Proclaim XR also uses Apple mobile devices and Bluetooth wireless technology.Ībbott developed the system based on positive results from a study that showed all 24 enrolled patients on a low-energy BurstDR dosing program experienced pain relief with less than six hours of battery use per day, while approximately half of those patients achieved pain relief with the lowest effective dose (less than two hours of battery use per day). The low doses extend the system’s battery life, the company said. The Proclaim XR neurostimulation system couples low-energy therapy with a low-dosing protocol to provide pain relief and preserve its battery.Ībbott said its BurstDR stimulation waveform was designed to mimic natural patterns found in the brain and to use low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain. Abbott (NYSE: ABT) announced today that the FDA has approved its low-dose, recharge-free spinal cord stimulation system with up to 10-year battery life for people in chronic pain.
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