US FDA grants 510(k) clearance to Relievant Medsystems for Intracept


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Relievant Medsystems has received US Food and Drug Administration (FDA) 510(k) clearance for the Intracept intraosseous nerve ablation system.

According to a company release, the Intracept system is the first specific therapy to relieve chronic low back pain care—caused by changes associated with degeneration of spinal vertebral bodies and the associated intervertebral discs—of at least six months duration that has not responded to at least six months of conservative care.

The system uses radio frequency energy delivered through specially designed instruments via a minimally invasive approach, to access and ablate the basivertebral nerve. The system can be used 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 SMART (Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) study; a 225-patient, level one, international, prospective, randomised, double-blind, sham-controlled clinical trial, which 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.

Key findings from the 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 three months showed that the mean Oswestry Disability Index 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 Oswestry Disability Index improvement of 20.5 points or 48% decrease from baseline at three 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 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 USA and worldwide,” says Alex DiNello, president and chief executive officer 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, principal investigator of the SMART study and professor and chairman of the Department of Orthopaedic Surgery at Beaumont Health System in Royal Oak, USA, states, “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.”