The FDA approval applies to the treatment of chronic back pain in those who have not had or are not eligible to receive back surgery. This is also known as non-surgical back pain.
Results from Abbott’s DISTINCT study supported the labeling expansion, according to a news release. The study demonstrated improved pain levels with Abbott’s proprietary BurstDR SCS technology. It also showed enhanced ability to perform daily activities and emotional well-being in people with chronic back pain.
“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 Dr. Timothy Deer, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, West Virginia. “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.”
The company said the new indication spans the entirety of its SCS portfolio in the U.S. That includes the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform. Eterna received expanded FDA indications last week.
All of Abbott’s U.S. SCS therapies feature its proprietary, low-energy BurstDR waveform.
About the Abbott BurstDR and the DISTINCT study
BurstDR, a form of stimulation therapy, delivers pulses of mild electrical energy. It achieves this without an abnormal sensation of tingling (paresthesia) to change pain signals traveling from the spine to the brian. Previous studies showed comfortability with BurstDR, with patients preferring it to traditional tingling tonic stimulation. Abbott said 70.8% of subjects with chronic pain preferred BurstDR.
The DISTINCT study enrolled 270 patients who suffered with pain for an average of 12.8 years. According to Abbott, it marks the largest randomized controlled trial in the non-surgical back pain population.
Results at six months for the first 200 patients demonstrated clear clinical evidence supporting BurstDR as an effective treatment. That remained the case at the 12-month follow-up. Additionally, 72.6% of people in the SCS study arm and 85.2% of those implanted achieved significant back pain reduction. That compares to just 7.1% in the conservative medical management arm.
Abbott said 91.4% of people who received SCS therapy obtained significant pain relief or significantly improved function. On average, those who received SCS therapy experienced a 69.7% reduction in pain.
“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.