Mainstay Medical has announced that the National Institute for Health and Care Excellence (NICE), a public body of the UK Department of Health, has issued a recommendation that the company’s ReActiv8 restorative neurostimulation therapy can be used in the National Health Service (NHS) in the UK—with special arrangements for clinical governance, consent, and audit or research.
According to Mainstay, ReActiv8 is currently the only technology offering restorative neurostimulation to the NHS for refractory mechanical chronic low back pain (CLBP).
The implantable medical device is designed to treat adults with intractable CLBP associated with multifidus muscle dysfunction, and is commercially available in the European Economic Area, Australia, USA and UK.
“Historically, mechanical CLBP pain therapies were aimed at only managing the symptoms, which is the pain associated with this pathology,” said Ganesan Baranidharan (Leeds Teaching Hospitals NHS Trust, Leeds, UK). “ReActiv8 is the only therapy available I am aware of where patients with many years of CLBP actually reverse and effectively rehabilitate their condition durably over a long period of time. ReActiv8 targets the cause of mechanical CLBP, not just the symptoms.
“The new NICE guidance is a major victory for patients and clinicians, which further confirms the positive patient outcomes we have seen to date. This new guidance will allow more patients to gain access to ReActiv8 within the UK and further afield.”