February 8, 2018 – SUNNYVALE, Calif.
Relievant Medsystems, a privately held medical device company that developed the Intracept® Procedure, a minimally invasive and clinically proven approach for the treatment of chronic low back pain (CLBP), announced today the publication of the pivotal SMART Trial data in the European Spine Journal. The SMART Trial is a Level 1, randomized, sham-controlled, double-blind clinical trial for chronic low back pain whose rigor, size, and clinical outcomes are unprecedented in the field of spine care. The study included 225 patients, 147 in the treatment arm and 78 in the sham arm, across 15 sites in the United States (U.S.) and 3 in the European Union (E.U.)
The published results demonstrated a statistically significant difference between the per protocol Intracept treatment arm and the sham arm for the primary endpoint of comparative change in Oswestry Disability Index (ODI) from baseline to three months (p = 0.019). Significant findings from the trial include:The published results demonstrated a statistically significant difference between the per protocol Intracept treatment arm and the sham arm for the primary endpoint of comparative change in Oswestry Disability Index (ODI) from baseline to three months (p = 0.019). Significant findings from the trial include:
- The per protocol INTRACEPT treatment arm demonstrated a mean ODI improvement of 20.5 points or 48% decrease from baseline at 3 months
- These patients also had a statistically significant decreases in pain at 6 and 12 months, as measured by Visual Analog Scale (VAS), with sustained 44% and 41% decrease in pain, respectively
- Excellent safety profile with no device-related adverse events
“The SMART trial confirms that Intracept is an important, new solution for CLBP with the strong results demonstrated by the significant and durable ODI decreases in this highly rigorous sham controlled randomized trial,” said Jeffrey Fischgrund, M.D., chairman, Orthopedics, Beaumont Hospital, Royal Oak and the principal investigator of the study. “The significant improvement in pain and function demonstrated by the SMART trial provides clear proof of the efficacy of this treatment. We are honored to have these data published in the European Spine Journal and look forward to building upon these results.”
“The Intracept Procedure represents a novel, minimally invasive option for the over 5 million indicated patients in the U.S who are suffering from CLPB for whom today’s treatment options have proven ineffective,” stated Kevin Hykes, President and Chief Executive Officer of Relievant. “Our ability to treat these patients early in the CLBP disease continuum can potentially avoid the later need for opioids, or more costly and invasive therapies.”
About the Intracept Procedure
Relievant‘s FDA 510(k) cleared Intracept System is based on ground breaking anatomic research that identified and demonstrated the role of the basivertebral nerve (BVN) in generating low back pain from the vertebral body endplates. The procedure uses a trans-pedicular, minimally invasive approach to reach the BVN near the center of the vertebral body, and uses radiofrequency energy to ablate the nerve; once ablated, these nerves no longer transmit pain signals. Spine Surgeons and Interventional Pain Specialists perform the Intracept Procedure under image guidance in the outpatient setting, with the entire procedure taking 60-90 minutes. Treated patients report nearly immediate relief of their back pain.
About the INTRACEPT Clinical Trial
Relievant is sponsoring the INTRACEPT Clinical Study to compare outcomes in CLBP patients treated with the Intracept procedure versus conservative care. . The primary efficacy endpoint is the mean change from baseline to 3 months post- treatment in the ODI. The primary endpoint will be evaluated in both the treatment and control groups with between-group comparisons used to assess the success of the Intracept System in reducing CLBP and health economics metrics. The INTRACEPT trial will enroll up to 150 patients at up to 20 leading medical centers across the U.S. Patients will be randomized 1:1 between the Intracept procedure arm vs control arm; Subjects in the control arm will continue non-surgical management therapies to treat their CLBP, but will have the opportunity to receive the Intracept procedure after 12 months. For additional information please visit IntraceptStudy.com.
About Chronic Low Back Pain (CLBP)
Low back pain is a widespread and often severely debilitating condition that is estimated to affect nearly 30% of the U.S. population, costing nearly $150 billion each year in medical treatment and lost productivity. Up to 15% of these patients experience CLBP. Patients suffering from CLBP typically initiate treatment with conservative therapies such as activity modification, medications, bracing, physical therapy, manipulation and steroid injections. Conservative therapies frequently fail to provide adequate pain relief and surgery is often performed to remedy structural defects in the spine in the hope that it will resolve a patient’s pain, but with often disappointing results. Relievant’s Intracept Procedure is a new, proven treatment option for patients who suffer from CLBP and have not responded to conservative therapies and who may not be candidates for surgery.
About Relievant Medsystems
Founded in 2006 and based in Sunnyvale, California, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from CLBP.
FDA has cleared the Intracept System for the following Indications for Use: The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.
As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure. Please see www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.
* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)