Relievant Medsystems, a privately held medical device company that has developed the Intracept® Procedure, a minimally invasive and clinically proven approach for the treatment of chronic low back pain, announced today the enrollment of the first patient in the INTRACEPT study – a Level I, prospective, randomized clinical trial comparing the Intracept Procedure to conservative care for patients with chronic low back pain.
The INTRACEPT study will enroll up to 150 patients at up to 20 centers across the U.S. The primary efficacy endpoint is the mean change from baseline to 3 months post- treatment in the Oswestry Disability Index (ODI). The INTRACEPT study is the second randomized controlled clinical trial sponsored by Relievant, following the successful results of the SMART* trial, which supported the Company’s FDA 510(k) clearance. The INTRACEPT study has similar patient inclusion and exclusion criteria and endpoints for safety and efficacy as the SMART trial, and will demonstrate the performance of the therapy compared to real-world conservative care, as well as generate additional Health Economic outcomes data to support the reimbursement approval process.
Steven R. Garfin, M.D., Chairman of the Department of Orthopedic Surgery at the University of California, San Diego Medical Center, has been named as Principal Investigator of the INTRACEPT study. Dr. Garfin is a world-renowned orthopedic surgeon specializing in adult spine care and previously served as president of the North American Spine Society (NASS). He has been involved in the design and assessment of numerous new surgical techniques and instruments to treat spinal disorders including lumbar and cervical anterior plating systems, kyphoplasty to treat painful osteoporotic vertebral fractures, artificial discs and biologic alternatives to bone grafts. Dr. Garfin’s work has contributed to the development of worldwide standards in surgical care of the spine.
“I am pleased to be taking part in the landmark INTRACEPT study,” said Dr. Steven Garfin. “This study will build on the recently presented results of the Level I SMART trial, led by Dr. Jeff Fischgrund, which demonstrated significant improvement in function, as measured by ODI, relief from pain, and impact on opioid consumption. I am hopeful that the comparison of the Intracept procedure to conservative care in the INTRACEPT study will provide appropriate clinical context for patients and physicians seeking options for the treatment of chronic low back pain.”
Jeffrey Fischgrund, M.D., Chairman of the Department of Orthopedics at Beaumont Hospital, Royal Oak and principal investigator of the SMART trial, will present results from the SMART trial at the North American Spine Society (NASS) at 3:58pm EST on Wednesday, October 25, 2017 in room W230AB at the Orange County Convention Center in Orlando, FL.
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. Relievant’s Intracept® System delivers targeted energy into the spine and blocks the transmission of pain signals from the BVN. This minimally invasive procedure provides orthopedic surgeons, neurological surgeons and interventionalists with a new way to provide clinically proven, lasting pain relief for CLBP. 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.
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.
* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)