ABBOTT RECEIVES FDA APPROVAL FOR ITS SCS SYSTEMS TO TREAT PEOPLE WITH NON-SURGICAL BACK PAIN

Abbott announced 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 labelling 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.

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.

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. 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:

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.

For U.S. important safety information on Abbott's SCS systems, visit: https://www.neuromodulation.abbott/us/en/important-safety-information.html

www.abbott.com