Abbott's spinal cord stimulation devices earned FDA approval to address chronic back pain for patients who aren't eligible for spine surgery, the medtech company said May 16.
The approval was backed by Abbott's Distinct study, which is the largest randomized controlled trial for spinal cord stimulation in chronic back pain patients who are ineligible for surgery, according to a news release. The study followed 270 patients and found that 91.4 percent of those recieving spinal cord stimulation saw significant pain relief or improved function.
The indication will span across Abbott's entire spinal cord stimulator portfolio including the recharge-free Proclaim and rechargable Eterna.