SCOTTSDALE, Ariz., March 8, 2018 /PRNewswire/ — Phoenix Spine today announced participation in a clinical study comparing the Intracept Procedure, developed by Relievant Medsystems, to conservative care for patients with chronic low back pain (CLBP). Phoenix Spine will be among 20 centers across the U.S. participating in the INTRACEPT study with up to 150 patients enrolled.
The INTRACEPT study’s primary efficacy endpoint is the mean change from baseline to 3 months post- treatment in the Oswestry Disability Index (ODI). This study will build on the recently presented reslatest medicineults of the Level I SMART trial, which demonstrated significant improvements in function and pain, and reduction of opioid consumption.
“Low back pain—whether coming from the disc or the vertebral body— can be agonizing and debilitating,” said Dr. Dan Lieberman, a neurosurgeon and Medical Director of Phoenix Spine Surgery Center. “Surgery has previously been the only real treatment available to these patients who fail conservative treatment. At Phoenix Spine, our goal is to treat back pain in the least invasive way possible. I look forward to participating in the INTRACEPT study and am hopeful that the outcomes of the Intracept procedure will compare favorably to conservative care and will provide appropriate clinical context for patients and physicians seeking options for the treatment of chronic low back pain.”
The Intracept System is based on ground breaking anatomic research that identified and demonstrated the role of the basivertebral nerve (BVN) in transmitting low back pain from the vertebral body endplates. The procedure uses a transpedicular, 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.
Patients will undergo the procedure in an ambulatory surgery setting and return home the same day of the surgery. The procedure uses imagorthopedic spine institutee guidance and does not require stitches or general anesthesia.
For more information on the INTRACEPT study, please visit http://intraceptstudy.com.
If you or someone you know is interested in joining the study, please call the Phoenix Spine Surgery Center at (602) 644-9107.
About Phoenix Spine
Phoenix Spine specializes in treating back pain with a patient-centered approach using ultra-minimally invasive options including Direct Visual Rhizotomy. For more information, visit https://www.phoenixspine.com.
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 medical manufacturing companiesinvasive 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)
Contact: Stan Miele, 602-256-2525, [email protected]
SOURCE Phoenix Spine