Mainstay Medical International, a medical device company focused on bringing to market ReActiv8, an implantable neurostimulation system to treat chronic low back pain, announces the completion of all implants in ReActiv8-B, its US IDE clinical study.
A total of 204 patients were implanted in the study. The implants were completed in accordance with the company’s planned timeline and Mainstay Medical expects to announce a full data readout towards the end of 2018.
Jason Hannon, CEO of Mainstay Medical, says: “Completing all implants in the ReActiv8-B study is a significant step for Mainstay and represents continued momentum in our efforts to bring ReActiv8 to patients in the US. We remain on track to have full study data towards the end of 2018. I would like to thank the study participants and investigators for their participation—we look forward to announcing the results of the study later this year.”
ReActiv8‑B is an international, multi-centre, prospective, randomised, sham-controlled triple-blinded study with one-way crossover, conducted under an IDE from the US Food & Drug Administration (FDA). The study is intended to gather data in support of a pre-market approval (PMA) application to the FDA, a key step towards the commercialisation of ReActiv8 in the USA. The study utilises an adaptive trial design, inclusive of an interim analysis. In December 2017 Mainstay Medical announced a positive outcome of the interim analysis.
The first commercial implant of ReActiv8 took place in Germany in early 2017.