Relievant Medsystems said today it won FDA 510(k) clearance for its Intracept intraosseous nerve ablation system designed for the treatment of chronic lower back pain.
The company touted the system as the 1st specific therapy to relieve chronic lower back pain which has persisted for at least 6 months and not responded to conservative care during the time, which is caused by changes associated with degeneration of spinal vertebral bodies.
“Chronic low back pain is one of the most prevalent and expensive medical problems in the United States and worldwide. Relievant’s minimally invasive Intracept System is intended to fill the large therapeutic gap that currently exists between conservative treatments, such as physical therapy or narcotics, and highly invasive surgical interventions such as spinal fusion surgery,” CEO Alex DiNello said in a press release.
The system is designed to use radio frequency energy delivered through specially designed instruments during a minimally invasive surgical procedure to access and ablate the basivertebral nerve.
“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,” principal Smart investigator Dr. Jeffrey Fischgrund of Royal Oak, Mich.’s Beaumont Health System said in prepared remarks.
The clearance followed the company’s 225-patient Smart study, which reported a mean improvement on the Oswestry Disability Index of 20.5 points, or 48%, from the baseline at 3 months, meeting the primary endpoint of the study.
Data also reported that 75% of the patients treated with Intracept demonstrated an ODI improvement equal to or greater than 1 points, with results sustained through 12 and 24 months of follow-up.
“We are pleased to receive the FDA’s 510(k) clearance and to see the excellent clinical outcomes obtained from the robust Smart study. They are important milestones for the Company, and we look forward to bringing this new therapeutic option to clinicians to enable them to treat their patients who suffer from chronic low back pain,” board chair Richard Mott said in a prepared release.