Mainstay Medical, an Ireland based medical device company, has secured approval from Ethics Committees in Australia to begin a clinical trial of ReActiv8, an implantable neurostimulation device designed for the treatment of people with Chronic Low Back Pain (CLBP).
The main objective of the trial is to investigate ReActiv8 as a treatment for adults with debilitating CLBP for whom surgery is not indicated. The trial has commenced the recruitment of patients at three clinical sites in Australia.
ReActiv8 is a small implanted device which stimulates the nerves responsible for contracting the key muscles that stabilize the lower back.
Mainstay Medical CEO Peter Crosby said the company’s novel approach of electrical stimulation to help restore the muscle control system is based on published scientific research, and the performance of the therapy was demonstrated in the recently completed European Feasibility Study.
"The energy and experience of the Mainstay Medical team has enabled us to complete the development of our innovative, therapy-specific device and obtain approval to start the ReActiv8 clinical trial within a year after the Feasibility Study results," Crosby added.
Earlier in June 2013, the company had presented the results from Mainstay Medical’s European Feasibility Study at the meeting of the International Neuromodulation Society in Berlin.
The results from the European Feasibility Study showed a statistically significant and clinically important improvement in key outcome measures, including reduction in pain and disability from CLBP and an improved quality of life.