GlobeNewswire11.30.21
Relievant Medsystems, a privately held medical device company transforming treatment of chronic low back pain (CLBP), released 24-month results from a Level 1, prospective, randomized, multi-center trial (INTRACEPT) that further validate the safety, effectiveness, and durability of the Intracept Procedure for patients with vertebrogenic CLBP.
The study reported outcomes for patients in the Intracept Procedure treatment arm that completed a 24-month follow-up visit. These patients achieved statistically significant and clinically meaningful improvements in pain, function, and quality of life from baseline at all follow-up timepoints through 24 months.
Patients in the Intracept Procedure treatment arm realized a 28.5 point (p<0.001) mean reduction in Oswestry Disability Index (ODI) and a 4.1 cm mean reduction in Visual Analog Scale (VAS) from baseline to 24 months post-procedure.
“This long-term data, from the treatment arm of our second Level I RCT, again show that patient benefits in function and pain persist following the Intracept Procedure,” said Tyler Binney, president and CEO of Relievant Medsystems.
“Not only are these 24-month results similar to the positive outcomes previously reported, including the 5-year results from our Level 1 SMART Trial, they also are consistent with the life-changing results physicians are seeing with their own vertebrogenic pain patients, validating the important role of the Intracept Procedure in the CLBP care pathway.”
The 24-month publication is currently available in the North American Spine Society Journal via open access and can be found here.
The Intracept Procedure is the only FDA-cleared treatment for vertebrogenic CLBP in the United States.
The study reported outcomes for patients in the Intracept Procedure treatment arm that completed a 24-month follow-up visit. These patients achieved statistically significant and clinically meaningful improvements in pain, function, and quality of life from baseline at all follow-up timepoints through 24 months.
Patients in the Intracept Procedure treatment arm realized a 28.5 point (p<0.001) mean reduction in Oswestry Disability Index (ODI) and a 4.1 cm mean reduction in Visual Analog Scale (VAS) from baseline to 24 months post-procedure.
“This long-term data, from the treatment arm of our second Level I RCT, again show that patient benefits in function and pain persist following the Intracept Procedure,” said Tyler Binney, president and CEO of Relievant Medsystems.
“Not only are these 24-month results similar to the positive outcomes previously reported, including the 5-year results from our Level 1 SMART Trial, they also are consistent with the life-changing results physicians are seeing with their own vertebrogenic pain patients, validating the important role of the Intracept Procedure in the CLBP care pathway.”
The 24-month publication is currently available in the North American Spine Society Journal via open access and can be found here.
The Intracept Procedure is the only FDA-cleared treatment for vertebrogenic CLBP in the United States.