US-based medical device company Relievant Medsystems has secured the US Food and Drug Administration (FDA) 510(k) clearance for its INTRACEPT intraosseous nerve ablation system to treat chronic lower back pain (CLBP).
The INTRACEPT System uses a minimally invasive approach and issues radio frequency (RF) energy which is transmitted through specially designed instruments to access and ablate the basivertebral nerve (BVN.)
The BVN is a sensory nerve within each vertebral body, which transmits the sharp, aching or throbbing pain during CLBP.
The device can be used by spine specialists to treat one or more levels between L3 and S1 in the lower spine.
The FDA approval follows the company’s Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART) study displaying a positive outcome after using the INTRACEPT System.
The level I, international, prospective, randomised, double-blind, sham-controlled clinical trial was conducted to determine the safety and efficacy of the INTRACEPT therapy to treat CLBP.
Beaumont Health System in Royal Oak, Michigan orthopaedic surgery department professor and chairman and SMART study principal investigator Jeffrey Fischgrund said: "We see patients every day with greater than six months of chronic low back pain that is not responsive to conservative care.
“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."
The INTRACEPT System treats patients who are suffering from CLBP for at least six months and is not responsive to at least six months of conservative care caused by changes associated with degeneration of spinal vertebral bodies and the associated intervertebral discs.