#Abbott spinal cord stimulator generator
#Abbott spinal cord stimulator trial

The same study that looked at device-related problems also found that 12% of participants experienced pain at the site of the implanted generator right after surgery and 4.5% developed infections. While complications related to the implanted devices are relatively common, they appear to be declining with advances in technology and surgeonsвЂ™ skills. 3 The most common complications were unintended movement (also called migration) of the leads, failed connections in leads, and breakage of leads. One extensive study in the medical literature found 38% of the research participants had device-related problems.

#Abbott spinal cord stimulator trial

'The more we learn and study the BurstDR stimulation waveform and low intermittent dose stimulation, the more we are able to apply this technology to real world situations.В AbbottВ is proud to be at the forefront of this new way of thinking about neurostimulation and developing truly life-changing therapies for people with debilitating conditions like chronic pain.Spinal cord stimulation and peripheral nerve field stimulation are considered generally safe, with the potential risks mainly related to the surgical procedures required for a trial period or long-term therapy. 'We're still only scratching the surface of what spinal cord stimulation can do in patients experiencing chronic pain,' saidВ Keith Boettiger, vice president ofВ Abbott'sВ neuromodulation business. About 30 percent of those patients develop depression or psychological effects when they develop a preoccupation with pain that makes it difficult to live a normal life.ДЄbbott'sВ Proclaim XR system lets physicians identify the lowest effective dose of BurstDR stimulation customized to each patient, optimizing system longevity while maintaining effective pain and symptom relief, and eliminating the need for recharging (for up to 10 years at low-dose settings). It is estimated that 50 million Americans live with chronic pain (pain that lasts longer than six months). The improvements in these two areas are critical factors in creating personalized care plans that help individuals feel better overall and treating the multiple aspects of pain.' 'We now have clinical evidence that Proclaim XR, using the BOLD dosing protocol, shows reductions in two standard measures of characterizing pain. Falowski, M.D., director of Functional Neurosurgery at Neurosurgical Associates ofВ LancasterВ inВ Pennsylvania. 'These collective data illustrate the important and promising physical and mental health benefits of the BurstDR stimulation waveform for people living with chronic pain,' saidВ Steven M. Patients also reported reduction in the impact of pain on daily life, resulting in patients becoming more active when measured at one year. 'Chronic pain is a broad term that doesn't accurately capture the variety of issues and symptoms people experience as a result of it,' saidВ Timothy Deer M.D., DABPM, president and CEO of The Spine and Nerve Center of the Virginias inВ Charleston, W.Va.В 'Whether the individual is worrying about being bedridden or experiencing severe pain for the rest of their lives, when we tell people about Proclaim XR, we can share with them the science behind the system to address physical and psychological aspects of pain.'ДЄdditional data was also presented at the North American Neuromodulation Society annual meeting from the 269-patient prospective, multi-center, single-arm, international TRIUMPH study, which found significant improvements in physical, mental, and emotional function were sustained for up to one-year, post-permanent implant. ODI is a diseases specific measurement to determine the patient's physical level of disability and measure change over a period of time. The research also found 78 percent of people had a baseline Oswestry Disability Index (ODI) score of 'severe,' 'crippling,' or 'bed bound.' After receiving treatment from a Proclaim XR implant for six months, 71 percent had a minimal or moderate ODI score, with 29 percent having a 'severe' or 'crippling' ODI score. PCS is a patient reported measure used to determine how pain affects mental state. Data from theВ BurstDR micrOdosing stimuLation in De-novo patients (BOLD) study found BurstDR reduced pain catastrophizing scale scores (PCS) by an average of 62 percent. Abbott announced positive results from a prospective, multicenter study, providing the scientific basis for the company's Proclaim XR recharge-free neurostimulation system for people living with chronic pain.