A new minimally invasive treatment option for chronic low back pain received FDA 510(k) clearance last week. Developed by Relievant Medsystems, Inc., a privately held medical device company, the INTRACEPT® Intraosseous Nerve Ablation System uses radio frequency (RF) energy, delivered through specially designed instruments via a minimally invasive approach to access and ablate the basivertebral nerve (BVN). It is described by the manufacturer as the first specific therapy to relieve chronic low back pain caused by degeneration of spinal vertebral bodies and associated intervertebral discs that has not responded to at least 6 months of conservative treatment. It can be used to treat 1 or more levels between L3 and S1 in the lower spine.
FDA clearance came after agency review of the company’s SMART (Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) study, a 225-patient, Level 1, international, prospective, randomized, double-blind, sham-controlled clinical trial, which evaluated the safety and effectiveness of the INTRACEPT therapy. The study used the Oswestry Disability Index (ODI) to assess disability level due to back pain. More than 75% of patients treated with INTRACEPT demonstrated an ODI improvement of 10 points or more, the minimal clinically important difference threshold. Principal study investigator Jeffrey Fischgrund, MD, Professor and Chairman of the Department of Orthopaedic Surgery at Beaumont Health System in Royal Oak, Michigan, stated, “INTRACEPT, as demonstrated in the rigorously designed and executed SMART trial, is an important breakthrough therapy with clinically meaningful results for patients and has an excellent safety profile."
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Read more about the procedure and study results here.
A news release on the FDA action may be read here.
Posted on July 28, 2016