Abbott Receives FDA Approval for Its Spinal Cord Stimulation Systems to Treat Chronic Back Pain in People Who Have Limited Surgical Options
- 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
- 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 status1,2
- Prior to enrollment in the study, participants suffered from severe, disabling chronic back pain for an average of 12.8 years2
ABBOTT PARK, Ill., May 16, 2023 -- Abbott (NYSE: ABT) announced today that the
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. 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.
"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
Abbott'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.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. Additional key findings from the DISTINCT study included:1,2,4
- 72.6% of people in the SCS study arm and 85.2% of those implanted achieved significant back pain reduction compared to only 7.1% in the conservative medical management arm
- 91.4% of people who received SCS therapy obtained significant pain relief or significantly improved function
- On average, people who received SCS therapy experienced a 69.7% reduction in pain
This new indication will span across the entirety of Abbott's SCS portfolio in the
"This FDA expanded indication approval for our SCS devices is a significant step forward in Abbott's goal to provide treatment access to those who suffer daily with chronic back pain but are not eligible for corrective surgery," said Pedro Malha, vice president, neuromodulation, Abbott.
More than 50 million people in the
BurstDR is a form of stimulation therapy that uses pulses—or bursts—of mild electrical energy without an abnormal sensation of "tingling" (known as paresthesia) to change pain signals as they travel from the spinal cord to the brain. Previous studies have demonstrated that BurstDR therapy is more comfortable and preferred to traditional tingling tonic stimulation by 70.8% of people with chronic pain.4 BurstDR stimulation is clinically proven to improve people's ability to perform everyday activities and reduce emotional suffering associated with chronic pain.7
Approximately 16 million adults in the
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
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1 Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT). https://clinicaltrials.gov/ct2/show/NCT04479787.
2 Clinical Summaries IFU - ARTEN600283815 A.
3 Abbott. Data on File. MAT-2305432 v1.0
4 Deer T, Gilligan C, Falowski S, et al. SCS in patients without options for corrective surgery; 12 month results from DISTINCT, a prospective RCT trial. Presented at NANS 2023.
5 Yong RJ, Mullins PM, Bhattacharyya N. Prevalence of chronic pain among adults in
7 Ehde DM, Dillworth TM, Turner JA. Cognitive-behavioral therapy for individuals with chronic pain: Efficacy, innovations, and directions for research. Am Psych Assoc. 2014;69(2):153-166.
8 Georgetown University Health Policy Institute. Chronic Back Pain. Accessed March 2023 https://hpi.georgetown.edu/backpain/.
9 Pitcher MH, Von Korff M, Bushnell MC, Porter L. Prevalence and Profile of High-Impact Chronic Pain in
10 Tagliaferri SD, Miller CT, Owen PJ, et al. Domains of chronic low back pain and assessing treatment effectiveness: a clinical perspective. Pain Pract. 2020;20:211–225.
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