A new study published by Eden Prairie, Minn.-based SynerFuse has shown that combining dorsal root ganglion stimulation with transforaminal lumbar interbody fusion in a single procedure is safe and feasible.
Patients in the study reported about a 70% reduction in both back and leg pain at 12 months, according to a June 12 news release from SynerFuse shared with Becker’s.
Here are seven more things to know about the study:
- The multicenter study enrolled 15 patients suffering from chronic low back pain or lumbosacral radiculopathy who required lumbar fusion surgery.
- There were no reported serious adverse events, no device revisions or explantations and one lead migration across 58 implanted leads with no loss of therapeutic benefit.
- Patients had a 71% reduction in back pain scores and 69% reduction in leg pain scores at 12 months.
- Responder rates, defined as at least 50% pain reduction, reached 67% for back pain and 73% for leg pain.
- Opioid use fell from 100% of patients immediately post-surgery to 20% by 12 weeks, with low utilization sustained through the full follow-up period.
- There are hundreds of thousands of lumbar fusion procedures performed in the U.S. each year. Even with successful surgeries, a substantial percentage of patients continue to experience chronic pain.
- The SynerFuse approach integrates neuromodulation during the initial fusion procedure, allowing surgeons to visualize and place DRG leads while the surgical site is exposed. The approach addresses neuropathic pain before it becomes a long-term issue.
Read the full study, published in the North American Spine Society Journal, here.
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