Action required: Please refresh your browser
We have recently implemented some changes that require a hard refresh of your browser: Please hold down the CTRL-key and press the F5 key.
After a successful hard refresh, this message should not appear anymore.
More details about this topic are available here »
Relievant Announces Publication of SMART Trial 24-Month Results | ||
By: Nasdaq / GlobeNewswire - 24 Apr 2019 | Back to overview list |
|
Intracept® Procedure Demonstrates Durable Results at 24 Months MINNEAPOLIS, April 24, 2019 (GLOBE NEWSWIRE) -- Relievant Medsystems, a privately-held medical device company developing minimally-invasive solutions for chronic low back pain (CLBP), today announced the publication of 24-month results from the SMART trial in the International Journal of Spine Surgery. A total of 106 of the 128 treatment arm patients in the SMART trial completed 24-month follow up. Data at 3 months and 12 months from the Level I SMART trial, a randomized, multi-center trial comparing the Intracept Procedure to sham, was previously published. The 24-month data demonstrated sustained improvement in pain, function, and resource utilization. Key results from the publication include:
“It is really exciting to see the improvement in pain and function previously reported at 3 and 12 months continued through 24 months,” said Alfred Rhyne, MD, Orthopedic Spine Surgeon, OrthoCarolina, Charlotte, NC. “While Intracept is not intended to treat all patients suffering from CLBP, the SMART trial has proven that Type 1 or 2 Modic endplate changes on MRI represent an objective, validated biomarker for the subset of CLBP patients that suffer from vertebrogenic pain, and who have shown in this trial to gain significant and durable pain relief with the Intracept Procedure.” “The SMART trial provides evidence that the Intracept Procedure not only improved pain and function, it also reduced opioid and spinal injection usage,” said Kevin Hykes, CEO of Relievant Medsystems. “Given the current opioid epidemic and the rising cost of healthcare, we are thrilled to offer a meaningful solution that provides lasting pain relief to millions of people suffering from chronic vertebrogenic low back pain.” The publication can be viewed here. About Relievant Medsystems About Chronic Low Back Pain (CLBP) About the SMART Clinical Trial About the Intracept Procedure As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure. Please visit www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device. For additional information, please visit www.relievant.com. Contact |
||
|
||
Copyright 2019 Nasdaq / GlobeNewswire | Back to overview list |