Additional key findings from the DISTINCT study included: 1,2,4 3 Results at six months for the first 200 patients demonstrated clear clinical evidence supporting BurstDR stimulation therapy as an effective treatment for chronic back pain and were sustained at the 12-month follow-up. "This new indication for Abbott's SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain."Ībbott's DISTINCT study, which enrolled 270 participants who suffered for an average of 12.8 years with pain, is the largest randomized controlled trial for SCS in people with chronic back pain when surgery is not an option. "To date, we have struggled with how to treat people who weren't considered a good surgical candidate because we didn't have clear, data-driven treatment options for non-surgical back pain," said Timothy Deer, M.D., FIPP, DABPM, president and chief executive officer of the Spine and Nerve Centers of the Virginias in Charleston, W.Va. However, these options are not effective for all people with chronic back pain, causing the treatment journey to feel complicated and uncertain for people who historically have had limited treatment options. Today, people who have few options for corrective surgery to address their chronic back pain are usually treated with combinations of therapies: physical therapy, chiropractic care and pain relievers. This labeling expansion was supported by results from the DISTINCT study, which demonstrated that Abbott's proprietary BurstDR™ SCS technology improved pain levels, ability to perform daily activities and emotional well-being in people with chronic back pain. Food and Drug Administration (FDA) has approved its spinal cord stimulation (SCS) devices for the treatment of chronic back pain in people who have not had or are not eligible to receive back surgery, known as non-surgical back pain. Prior to enrollment in the study, participants suffered from severe, disabling chronic back pain for an average of 12.8 years 2ĪBBOTT PARK, Ill., /PRNewswire/ - Abbott (NYSE: ABT) announced today that the U.S.Results for the first 200 patients demonstrated that people who used the company's SCS products experienced significant relief and improvements in pain, function, quality of life and psychological status 1 ,2.FDA approval was backed by Abbott's DISTINCT study, the largest randomized controlled trial for spinal cord stimulation (SCS) in people with chronic back pain when surgery is not an option.
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