Relievant Medsystems said it has halted enrollment in a clinical trial of its Intracept lower-back pain device due to the device’s superiority over non-surgical management.
The Level I Intracept study found a “highly significant reduction” in the Oswestry Disability Index (ODI) score in patients treated with the Intracept procedure over patients in the non-surgical management arm. The trial’s independent data management committee recommended that investigators stop enrollment and offer Intracept treatment to control-arm patients, according to the Minneapolis, Minn.-based company.
The interim analysis of the primary endpoint 104-participant trial demonstrated a 20.9 point difference in mean ODI reduction at three months between the Intracept arm and the non-surgical management arm. The Intracept-treated patients reported a 25.3 point reduction in ODI from baseline at three months. One-year results from a prior study released in February 2018 showed a statistically significant difference between patients treated with Intracept and a sham treatment cohort.
“This is the second Level I study that has demonstrated clinically significant improvement in pain and function for patients with modic changes on MRI and solidifies the Intracept procedure as a compelling early treatment option for patients with (chronic lower back pain),” said principal investigator Steven Garfin, M.D., interim dean, University of California San Diego School of Medicine, in a prepared statement.
“Stopping a Level I trial early for superiority is an extremely rare event and we are thrilled with this result,” said Relievant Medsystems CEO Kevin Hykes. “The Intracept procedure has demonstrated compelling and consistent clinical results in both sham-controlled and real-world Level I studies. The combined strength of these studies provides convincing evidence of the outcomes that patients and physicians can expect from the Intracept procedure.”
The full results of the Intraceptstudy are expected to be presented and published later in 2019.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.