![]() 5Ībbott developed Eterna based on extensive studies with patients, physicians and caregivers to understand the unmet needs of people living with chronic pain. Food and Drug Administration (FDA) approval of the company's Eterna™ spinal cord stimulation (SCS) system the smallest implantable, rechargeable spinal cord stimulator currently available on the market for the treatment of chronic pain.* 4 Eterna SCS utilizes Abbott's proprietary low-dose BurstDR™ stimulation, the only SCS waveform technology with the highest level of clinical evidence (1A evidence), proven to reduce pain 23% more than traditional waveform technology approaches. 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 §1,2,3Ībbott (NYSE: ABT) today announced the U.S.Food and Drug Administration (FDA) approved Abbott's Eterna™ spinal cord stimulation (SCS) system for the treatment of chronic pain This may be due to the unique mechanism of action with the stimulation design involving the emotional-affective medial pain pathway in the brain.Ĭatastrophizing Depression Neuromodulation Passive recharge burst Quality of life Spinal cord stimulation.Ĭopyright © 2021 Elsevier Inc. Our results showed that B-SCS appears to be as effective in a chronic pain population with high psychological distress as in those without distress. In both groups, 81% were satisfied or very satisfied with the pain relief provided. Psychological distress did not impact outcomes after SCS therapy composite multi-responder rates were similar in the 2 groups throughout the follow-up period. Health-related quality of life was 82% higher in the PD group at 24 months, reaching levels similar to the ND group. Notably, more than half of the PD patients on antidepressants discontinued or decreased their medication. Two years after implant, 71% were no longer clinically catastrophizing and 58% were no longer clinically depressed. Baseline measures indicated a more severe chronic pain profile and worse quality of life in the PD group. Of the 128 participants with 24-month data, 31 (24%) and 54 (35%) met the criteria for PD and ND, respectively. JJY is a consultant for Abbott and has received <$2,500 in lifetime consulting fees from Abbott. JMH is a consultant for Abbott and has received $50,000 in lifetime consulting fees from Abbott. All patients were implanted with a B-SCS system and completed data collection for the 24-month follow-up visit. Nondistressed (ND) patients had scores below these thresholds on both scales. Psychological distress (PD) was defined as a baseline score of ≥ 30 on the Pain Catastrophizing Scale (PCS) and ≥ 10 on the Patient Health Questionnaire Depression scale (PHQ-9). Additionally, patient satisfaction and patient global impression of change were assessed at all follow-up intervals. Psychological and functional outcomes as well as pain intensity and impact of pain on life were administered at baseline and all follow intervals. Two subsets of study patients were identified those with (n=31) and those without (n=54) high psychological distress. The purpose of TRIUMPH was to assess long-term (2 years) safety and effectiveness of spinal cord stimulation for chronic pain in the trunk and/or limbs using a passive recharge enabled burst spinal cord stimulation (B-SCS) system. This proprietary waveform may uniquely attenuate the emotional aspects of chronic pain given its affects on the medial pain pathway projecting to the dorsal anterior cingulate cortex and anterior insula.ĭata were extracted from the prospective, multi-center, single-arm, international TRIUMPH study. To evaluate whether high psychological distress, defined as clinically elevated levels of catastrophizing and depression, is associated with poorer outcomes after spinal cord stimulation utilizing a passive recharge burst stimulation design. Psychological characteristics such as catastrophizing and depression have been shown to negatively impact outcome prognosis after spinal interventions.
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