Mainstay Medical granted CE mark for lower back pain system
Irish medical firm Mainstay Medical has received the CE Mark approval for its implantable system to treat disabling chronic back pain.
After acquiring the mark for ReActiv8 Mainstay can now begin the commercialisation of the product in Europe.
Mainstay chief executive Peter Crosby said the marking is a "pivotal" moment for the company.
“We believe ReActiv8 has the potential to change the lives of millions of people who currently have limited treatment options for their chronic low back pain.”
During patient-controlled treatment sessions, ReActiv8 stimulation causes repetitive contractions of the key stabilizing muscles in the back to support recovery from chronic low back pain and related symptoms.
Orthopedic surgeon at the University Hospital in Bonn, Germany Dr. Robert Pflugmacher outlined the potential patients for the new device.
“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 exciting new option we can offer them."