Mainstay Medical International, a medical device company focused on bringing to market ReActiv8, an implantable neurostimulation system to treat disabling chronic low back pain (CLBP), announces the first sale and implant of ReActiv8 in Germany.
The ReActiv8 implant was performed by Dr. med. Francis Kilian, Orthopedic and Neurosurgeon at the Catholic Hospital Koblenz-Montabaur in Koblenz Germany.
Dr. Kilian commented: “As spine surgeons we are always looking to address the underlying cause of a patient’s condition but until now we had no effective option to offer to patients with Chronic Low Back Pain due to impaired control of their back muscles.
“ReActiv8 represents a significant breakthrough for this large group of patients who are not candidates for spine surgery and fills an important void in our restorative treatment portfolio.”
ReActiv8 works by electrically stimulating the nerves responsible for contracting the key stabilizing muscles of the lumbar spine. Activation of these muscles to restore functional spine stability has been shown to facilitate recovery from CLBP.
Peter Crosby, CEO of Mainstay, commented: “The first sale and implant of ReActiv8 in Germany is an important milestone for Mainstay.
“We are fully committed to working with our customers to integrate ReActiv8 into their routine clinical practice and provide a new option for many people suffering from chronic low back pain.”
Mainstay’s European commercial activities for ReActiv8 are initially focused on Germany where the Company aims to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. As the Company gains experience and momentum, it will expand to other sites and countries.
Mainstay received CE Marking for ReActiv8 supported by positive results from the ReActiv8-A Clinical Trial that demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other treatment options.