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.