The Intracept system is the specific therapy that will relieve chronic low back pain (CLBP) of at least six months duration that has not responded to about six months of conservative care caused by changes associated with degeneration of spinal vertebral bodies and the associated intervertebral discs.
Intracept is a patent-protected and minimally invasive, implant-free therapy that uses radiofrequency energy delivered into the vertebral body of the spine to ablate the BVN.
BVN is a sensory nerve within each vertebral body, which carries the sharp, aching or throbbing pain experienced with degenerated vertebral bodies.
The approval was based on the company’a surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART) study.
SMART trial is an international, prospective, randomized, double-blind and sham-controlled clinical study, which assessed the safety and effectiveness of the Intracept therapy to treat chronic low back pain.
Relievant Medsystems president and CEO Alex DiNello said: "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."
Relievant directors board executive chairman Richard Mott said: "We are pleased to receive the FDA's 510(k) clearance and to see the excellent clinical outcomes obtained from the robust SMART study.”
