ReActiv8 Neurostimulation therapy recommended to be used in the National Health Service; Special arrangements designation to increase access to ReActiv8 for patients
Mainstay Medical Holdings plc announced today that the National Institute for Health and Care Excellence (NICE), a public body of the Department of Health that carries out evidence-based health technology assessments by independent committees, has issued a recommendation that ReActiv8® Restorative Neurostimulation™ can be used in the National Health Service in the U.K., with special arrangements for clinical governance, consent, and audit or research. ReActiv8 is currently the only technology offering restorative neurostimulation to the NHS for refractory mechanical chronic low back pain (CLBP).
“U.K. physicians have some of the most extensive experience with ReActiv8 globally. We are thankful to NICE for recognizing this experience, as well as the substantial body of global evidence we have developed in support of the efficacy and safety of this ground-breaking therapy, “ said Jason Hannon, CEO of Mainstay Medical. “This new guidance will enable patients to have greater access to the therapy when previous treatment options have not proven successful. We look forward to supporting physicians across the U.K. going forward and to continued improvement in patient outcomes.”
“Historically, mechanical CLBP pain therapies were aimed at only managing the symptoms, which is the pain associated with this pathology,” said Dr. Ganesan Baranidharan, Consultant in Anaesthesia and Pain Medicine, Leeds Teaching Hospitals NHS Trust. “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 U.K. and further afield.”
The NICE publication can be found here: Evidence | Neurostimulation of lumbar muscles for refractory non-specific chronic low back pain | Guidance | NICE
About ReActiv8®
ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.
About Mainstay Medical
Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation™ system, ReActiv8®, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.
Further information can be found at www.mainstaymedical.com.