4-year data backs Relievant Medsystems’ Intracept ablation procedure

2023-07-21

临床结果

Intracept — a minimally invasive, FDA-cleared, same-day, outpatient procedure — treats chronic vertebrogenic low back pain. The procedure utilizes targeted radiofrequency energy to ablate the basivertebral nerve (BVN). This stops the nerve from transmitting pain signals to the brain. The procedure takes approximately one hour to perform. Data from the study further demonstrated the safety, effectiveness and long-term durability of Intracept. The company just last month reported positive three-year data for the ablation procedure. Minneapolis-based Relievant saw its study’s abstract named one of the “Top Abstracts” at the American Society of Pain & Neuroscience (ASPN) Annual Conference in Miami. Lead author Dr. Jad Khalil presented the study’s results. Khalil serves as associate professor of orthopedic surgery and director of the spine surgery fellowship at Beaumont Hospital, Royal Oak, Michigan. “The four-year results further support the use of the Intracept Procedure for patients with vertebrogenic back pain,” said Khalil. “Basivertebral nerve ablation is shifting the paradigm of how we understand and treat this distinct type of chronic low back pain and provides a proven treatment path for patients with this often debilitating condition.” About the Relievant Medsystems study results The study included 94 patients successfully treated with the Intracept procedure who also completed four-year study visits. They achieved statistically significant, clinically meaningful and durable improvements in both pain and function. At four years post-procedure, the study saw mean improvements in Oswestry Disability Index (ODI) of 30.8 points and in numeric pain score (NPS) of 3.9 points compared to baseline. These results fall in line with previous clinical trials, Relievant said in a news release. The study also demonstrated that 66.7% fewer patients actively took opioid medications for low back pain compared to baseline. Only 4.3% received therapeutic injections post-procedure for the same pain etiology treated with Intracept. Relievant said that 83% of patients reported satisfaction with their results. The company noted that 71% resumed the level of activity they enjoyed prior to low back pain onset. Additionally, the study saw no serious device- or procedure-related adverse events across four years. “These latest findings illustrate the long-term effectiveness of the Intracept Procedure and are consistent with previously published results that measured outcomes at five years,” said Tyler Binney, president and CEO of Relievant Medsystems. “More than 10,000 patients have been treated with the Intracept procedure and we look forward to continuing to partner with physicians to bring patients lasting relief from vertebrogenic pain.”

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