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FDA Approves Neurostimulation Device for Chronic Low Back Pain
The FDA recently approved an implantable neurostimulation system for the treatment of chronic low back pain.
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The US Food and Drug Administration recently approved ReActive8® (Mainstay Medical), an implantable neurostimulation system for the treatment of chronic low back pain (LBP).
More specifically, ReActive8 is approved as an aid in the management of intractable chronic LBP associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery or mechanical stimulation, according to the June 22, 2020 press release from Mainstay Medical.
The approval was based on results from the ReActive8-B clinical study, a prospective, international, multi-center, randomized, active sham-controlled, blinded trial of 204 patients with chronic LBP refractory to physical therapy and medical management.
Patients were implanted with ReActive8 and randomized 1:1 to therapy or control. The device delivered enough stimulation to elicit episodic contractions of the multifidus muscle to the treatment group and low stimulation (no expected effect) to the control group.
The primary endpoint was a comparison of responder rates between the 2 groups as measured on the visual analog scale of pain.
Researchers found that the responder rate at 120 days was 56% in the treatment group vs 47% in the control group, a difference that was not found to be statistically significant. Also, the study showed that among the 60 patients who crossed over to treatment from the control group, 68% were considered responders.
“ReActiv8 fills an important unmet clinical need of patients suffering from chronic low back pain. Patients indicated for ReActiv8 therapy have generally tried numerous other treatments, including physical therapy and pain medications, and many are on long-term opioids to manage their pain,” said principal investigator Chris Gilligan MD, MBA, chief, division of pain medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham & Women’s Hospital, Boston, Massachusetts, in the press release. “I have seen ReActiv8 provide durable improvements in back pain, the disabling effects of back pain, and quality of life.”
