Abbott has received approval from the US Food and Drug Administration (FDA) for its spinal cord stimulation (SCS) devices to treat chronic back pain in people who are not eligible to undergo corrective back surgery.
The expansion of labelling was backed by findings from Abbott’s DISTINCT study, a randomised controlled trial for SCS in chronic back pain patients when surgery is not an option.
The study was conducted to evaluate the positive impact of Abbott’s BurstDR SCS technology on individuals suffering from chronic back pain.
The study revealed enhancements in pain levels, daily activities and emotional well-being in patients treated with the device.
Abbott recruited 270 participants, who experienced chronic back pain for an average of 12.8 years, in the trial.
The results at the end of six months in the initial 200 patients provided evidence proving the efficacy of BurstDR stimulation therapy as a remedy for chronic back pain.
Furthermore, these results were sustained during the 12-month follow-up period.
Abbott neuromodulation vice-president Pedro Malha said: “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.”
BurstDR represents a type of stimulation therapy that uses mild electrical energy in the form of pulses or bursts.
It does not induce a tingling sensation but modifies pain signals during their journey from the spinal cord to the brain.
The latest approval covers all of Abbott’s SCS portfolio in the US, comprising the Proclaim SCS family and the Eterna SCS platform.
The company’s SCS therapies in the US incorporate the BurstDR waveform.