Mainstay Medical International has received CE mark approval for ReActiv8, its proprietary implantable neurostimulation system designed to treat disabling chronic low back pain.
According to a press release, the CE mark approval is 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 treatment options.
“CE marking is a pivotal milestone for Mainstay. Our team has been working tirelessly towards making ReActiv8 commercially available to physicians and their patients,” says Peter Crosby, chief executive officer of Mainstay.
ReActiv8 is indicated as an adjunct to medical management of chronic low back pain for relief of pain in adults who have attempted at least medical management and physical therapy. During patient-controlled treatment sessions, ReActiv8 stimulation causes repetitive contractions of the key stabilising muscles in the back to support recovery from chronic low back pain and related symptoms.
Robert Pflugmacher, orthopaedic surgeon at the University Hospital in Bonn, Germany says, “We see several new chronic low back pain patients every week who are not indicated for surgery and who meet the indications for ReActiv8. Rather than sending them home untreated, we now have an option we can offer them. As orthopaedic surgeons, ReActiv8 meets our objective of addressing the underlying functional causes of chronic low back pain, and the straightforward implant procedure utilises skills and techniques familiar to us.”
Mainstay intends to conduct a post-market clinical follow-up to gather additional long term data.