- 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
/PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S.
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. 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.2
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 Charleston,
W.Va. "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."
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 U.S., which includes the recharge-free
Proclaim™ SCS family and the rechargeable Eterna SCS platform. All
of Abbott's SCS therapies in the U.S. feature the company's
proprietary, low-energy BurstDR waveform.
"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 U.S. suffer from chronic
pain.5 According to the U.S. Pain Foundation, chronic
pain is the leading cause of people going to the doctor and costs
the nation approximately $635 billion
each year in healthcare, disability and lost productivity
costs.6 SCS, also known as neurostimulation, has been
recommended by doctors for more than 50 years to help people manage
chronic pain and improve their quality of life. Devices used for
SCS consist of thin wires placed between the spinal cord and the
vertebrae and a small implant placed under the skin in the lower
back that helps disrupt pain signals before they can reach the
brain.
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 U.S. suffer from chronic
back pain, with an estimated 10 million adults suffering from
high-impact chronic pain (HICP), which is defined as individuals
who face significant levels of life-interference from the
condition.8,9 Additionally, low-back pain is
commonly reported by HICP individuals and is often accompanied by
negative effects on mental health, quality of life and
productivity.9,10
For U.S. important safety information on the Abbott's SCS
systems, visit:
https://www.neuromodulation.abbott/us/en/important-safety-information.html.
About Abbott
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.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
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 the United
States. Pain. 2022 Feb
1;163(2):e328-e332.
6 U.S. Pain Foundation. Chronic Pain Facts.
https://uspainfoundation.org/pain/. Accessed June 27, 2022.
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 the United States. J Pain. 2019
Feb;20(2):146-160. doi: 10.1016/j.jpain.2018.07.006. Epub 2018
Aug 7. PMID: 30096445; PMCID:
PMC8822465.
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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SOURCE Abbott