Tag: ReActiv8
Mainstay announces receipt of European and Australian approvals for ReActiv8 MRI...
Mainstay Medical has announced that it has received regulatory approvals in the European Union, the UK and Australia of full-body magnetic resonance imaging (MRI)...
Mainstay announces publication of five-year follow-up data from ReActiv8-B trial
Mainstay Medical has announced the publication of the five-year follow-up from its ReActiv8-B randomised, sham-controlled, double-blinded trial in Neuromodulation: Technology at the Neural Interface.
There...
Mainstay receives expanded MRI labelling from US FDA for ReActiv8 system
Mainstay Medical has announced that the US Food and Drug Administration (FDA) has approved full-body magnetic resonance imaging (MRI) conditional labelling for the ReActiv8...
Mainstay Medical announces completion of US enrolment in RESTORE clinical trial
Mainstay Medical has announced the completion of enrolment in its RESTORE randomised clinical study of ReActiv8 for the treatment of intractable chronic low back...
Mainstay announces publication of three-year data from post-market follow up of...
Mainstay Medical recently announced the publication of three-year clinical data from the post-market clinical follow-up (PMCF) study of 33 ReActiv8 patients at five medical...
Mainstay announces publication detailing economic impact of restorative neurostimulation
Mainstay Medical has announced the publication of a paper, titled “Effect of Restorative Neurostimulation on Major Drivers of Chronic Low Back Pain Economic Impact",...
Mainstay announces publication of post-market data from ongoing chronic low back...
Mainstay Medical has announced the publication of data from a single-centre, real-world study with one-year clinical follow-up of patients selected from its ReActiv8-C study,...
UK NICE publishes interventional procedure guidance for ReActiv8 restorative neurostimulation
Mainstay Medical has announced that the National Institute for Health and Care Excellence (NICE), a public body of the UK Department of Health, has...
Mainstay Medical announces positive efficacy and safety outcomes from ReActiv8-B trial
Mainstay Medical has announced the publication of two-year patient outcomes data from its pivotal ReActiv8-B clinical trial. The data, which are published in Neuromodulation:...
Mainstay Medical launches implantable restorative neurostimulation system in USA
Mainstay Medical has announced the limited US commercial launch of ReActiv8, its implantable restorative neurostimulation system to treat intractable chronic low back pain. The...
Mainstay Medical announces FDA approval of ReActiv8 neurostimulation system for chronic...
Mainstay Medical has announced that the US Food and Drug Administration (FDA) has approved the company’s premarket approval (PMA) application for ReActiv8, its implantable...
Mainstay Medical announces headline results from ReActiv8-B clinical study
Mainstay Medical International, a medical device company focused on commercialising ReActiv8, an implantable restorative neurostimulation system designed to treat an underlying cause of disabling...
Mainstay Medical announces the completion of all implants in the ReActiv8-B...
Mainstay Medical International, a medical device company focused on bringing to market ReActiv8, an implantable neurostimulation system to treat chronic low back pain, announces...
Final ReActiv8 results: neurostimulation safe and effective treatment for chronic low...
Following implantation of a restorative neurostimulation system significant improvements were observed in pain, disability and quality of life compared to baseline in patients with...
Jason Hannon to replace Peter Crosby as Mainstay chief executive officer
Jason Hannon has been announced as successor to Peter Crosby as chief executive officer of Mainstay Medical, with effect from October 9, 2017. According...
First commercial implantation of Mainstay Medical’s ReActiv8 performed in Germany
The first commercial implantation of Mainstay Medical’s ReActiv8 has taken place in Germany.
The implantation was performed by Francis Kilian, orthopaedic and neurosurgeon at the...
ReActiv8-A sustains performance at one year in clinical trial
Mainstay Medical International has announced the one-year results from the ReActiv8-A Clinical Trial, an international, multi-centre, prospective, single arm trial for ReActiv8 in people...
CE mark granted to Mainstay Medical for ReActiv8
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...
