FDA Clears Intraosseous Nerve Ablation System for Chronic Low Back Pain

Relievant Medsystems, Inc., a privately held medical device company pioneering the therapy of nerve ablation within vertebral bodies for the treatment of chronic low back pain, announced today (21 July) that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the INTRACEPT Intraosseous Nerve Ablation System.
 
The INTRACEPT System is the first specific therapy to relieve chronic low back pain (CLBP) of at least six months duration that has not responded to at least six months of conservative care caused by changes associated with degeneration of spinal vertebral bodies and the associated intervertebral discs.
 
The INTRACEPT System uses radio frequency (RF) energy, delivered through specially designed instruments via a minimally invasive approach 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 experienced with degenerated vertebral bodies. Spine specialists can use the INTRACEPT System to treat one or more levels between L3 and S1 in the lower spine.
 
The FDA clearance followed the Agency’s review of the Company’s landmark SMART (Surgical Multi-CenterAssessment 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, that evaluated the safety and effectiveness of the INTRACEPT therapy for the treatment of chronic low back pain. Patients were followed at two and six weeks, and at three, six, 12 and 24 months. Endpoints included Oswestry Disability Index (ODI), a validated assessment that measures a patient’s disability due to their back pain.


 
Key findings from the Level 1 SMART study include:
 

• For patients who successfully received the intended therapy and completed the follow-up, results of the primary endpoint analysis for this per protocol population at 3-months showed that the mean ODI improvement observed in the INTRACEPT treatment arm was statistically superior to the sham arm (p = 0.019).
• In these patients, the INTRACEPT treatment arm demonstrated a mean ODI improvement of 20.5 points or 48% decrease from baseline at 3 months.
• In this same patient population, greater than 75% of patients treated with INTRACEPT demonstrated an ODI improvement equal to or greater than 10 points, the minimally clinically important difference (MCID) threshold.
• Results in the INTRACEPT treatment arm were sustained through 12 and 24 months of follow-up.

 
“Chronic low back pain is one of the most prevalent and expensive medical problems in the United States and worldwide,” said Alex DiNello, President and CEO of Relievant Medsystems. “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.”
 
Jeffrey Fischgrund, MD, principal investigator of the SMART study and Professor and Chairman of the Department of Orthopaedic Surgery at Beaumont Health System in Royal Oak, Michigan stated, “We see patients every day with greater than 6 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.”
 
“We are pleased to receive the FDA’s 510(k) clearance and to see the excellent clinical outcomes obtained from the robust SMART study,” Richard Mott, Relievant’s Executive Chairman of the Board of Directors stated. “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.”