Intralink-Spine, is pleased to announce that early clinical study data has been obtained regarding the use of its Réjuve system for the treatment of low back pain.
Each of the four patients treated in late June by orthopaedic surgeon Harwant Singh at Pantai Medical Center (Kuala Lumpur, Malaysia) had a reduction in Visual Analog Scale pain score of 83%-100%, two-weeks post-procedure compared to pre-procedure levels, with a 93% average reduction.
Disability, based on the Oswestry Disability Index (ODI), was reduced 57%-100% with an 84% average reduction. While each of the patients is happy with the treatment effects two-weeks post-procedure, Tom Hedman, chief scientific officer for ILS, is the first to note that it is very early in the clinical trial phase with more patients and data yet to be acquired.
“The patients received fluoroscopic image-guided injections of the Réjuve medical device in the lumbar intervertebral discs, with two posterolateral injections per treated level,” states Singh. And, according to Hedman, “These initial data support our belief that this device can be safely and effectively delivered to the affected disc using our protocol and standard fluoroscopic techniques.”