Tag: ReActiv8

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 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...

Therapeutic Goods Administration requests additional clinical data on Mainstay Medical’s ReActiv8

Mainstay Medical, a medical device company focused on bringing to market ReActiv8, an implantable restorative neurostimulation system to treat disabling chronic low back pain,...
Jason Hannon

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. The transition will come into effect on...

Mainstay Medical’s ReActiv8 clinical trial passes enrolment mid-point

Over half the required number of implants in Mainstay Medical’s ReActiv8-B clinical trial have been performed. The clinical trial is investigating the company’s novel...

First commercial implantation of ReActiv8 in Ireland takes place

The first Irish sale and implantation of Mainstay Medical’s ReActiv8 has taken place in Dublin. The implantation was performed at St Joseph’s Hospital, part...

ReActiv8’s clinically important disability, pain and quality-of-life improvements sustained at one-year

The disruption of lumbar multifidus muscle control is one factor involved in many cases of functional instability and chronic low back pain. Whilst targeted...

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...

Mainstay Medical applies for Australian marketing approval for ReActiv8

Mainstay Medical has applied for ReActiv8 to be admitted to the Australian Register of Therapeutic Goods (ARTG) which would allow for commercialisation in Australia. Mainstay’s...

Mainstay Medical ReActiv8-B clinical trial enrols first subject

The first subject has been enrolled in the ReActiv8-B Clinical Trial of the Mainstay Medical ReActiv8 device. The trial is intended to gather data...

Mainstay Medical ReActiv8-A sustains performance at one year in clinical trial

Mainstay Medical has announced the one-year results from the ReActiv8-A Clinical Trial, an international, multi-centre, prospective, single arm trial for ReActiv8 in people with...