Relievant Medsystems has announced four-year results from two clinical trials demonstrating the safety, effectiveness and durability of its Intracept procedure for patients with vertebrogenic pain.
The study, led by Jad Khalil, MD, associate professor of orthopedic surgery and director of the spine surgery fellowship at Beaumont Hospital in Royal Oak, Mich., included 94 patients who were successfully treated with the Intracept procedure, according to a July 20 press release.
The patients achieved statistically significant, clinically meaningful and durable improvements in both pain and function at their four-year study visits.
The study found that 66.7 percent fewer were actively taking opioids for pain compared with the baseline, 83 percent of patients were satisfied with the procedure, 71 percent of patients had resumed the same level of activity as before the procedure, and no serious device-related adverse events were reported.
Relievant's Intracept procedure is the only FDA-cleared treatment for chronic vertebrogenic low back pain.