The first subject has been enrolled in the ReActiv8-B Clinical Trial of the Mainstay Medical ReActiv8 device. The trial is intended to gather data in support of an application for pre-market approval from the US Food and Drug Administration (FDA).
The first subject was enrolled at the Genesis Research Services centre in Newcastle, Australia by Marc Russo, and if all eligibility criteria are met, will be implanted with ReActiv8 within a few weeks.
ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilise the lumbar spine. According to a press release, activation of these muscles to restore functional stability has been shown to facilitate recovery from chronic low back pain. Mainstay received CE marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A clinical trial which demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling chronic low back pain and few other options.
Chris Gilligan, chief of the Division of Pain Medicine, co-director of the Spine Center at Beth Israel Deaconess Medical Center in Boston, USA, and principal investigator for the ReActiv8-B Clinical Trial says, “Chronic low back pain is a major global challenge, and many patients have been suffering from the condition for many years and are left with few treatment options. ReActiv8 offers a unique new approach which addresses cause and not simply symptoms. We look forward to gathering the clinical evidence required for Mainstay to make an application for pre-market approval, which would make ReActiv8 also commercially available to patients in the USA.”