Mainstay Medical wins CE Mark for ReActiv8 neurostim

Mainstay Medical (EPA:MSTY) said today it won CE Mark approval for its ReActiv8 implantable neurostimulation system designed to treat chronic lower back pain. The device was approved based off data from the company’s ReActiv8-A trial, which reported statistically significant, lasting improvements in pain, disability and quality of life in patients with chronic low back pain and few 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. 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,” CEO Peter Crosby said in a press release. The ReActiv8 is indicated as an adjunct to the management of chronic low back pain, to be used to for the relief of pain in adults who have attempted previous medical management and physical therapy, Mainstay Medical said. “ReActiv8 is an innovative use of neurostimulation for the treatment of chronic low back pain and the clinical data from the ReActiv8-A trial are compelling. Neurosurgeons in Germany have a track record of embracing important innovations and we are looking forward to offering ReActiv8 to patients who until now were facing the prospect of disabling chronic low back pain for the rest of their lives,” Dr. Stefan Schu of Duisburg, Germany’s Sana Hospital said in prepa...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Neuromodulation/Neurostimulation Regulatory/Clearance Mainstay Medical Source Type: news