Phoenix Spine Announces Participation in the INTRACEPT Study for the Treatment of Chronic Low Back Pain
SCOTTSDALE, Arizona, March 8, 2018
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 results 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 image guidance and does not require stitches or general anesthesia.
About Phoenix Spine
Phoenix Spine specializes in treating back pain with a patient-centered approach using ultra-minimally invasive options including Direct Visual Rhizotomy.
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.