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Trial Results Fail To Support Mainstay Medical's Neuromodulation Device

 
• By Catherine Longworth

Mainstay Medical says it will move forward with a US PMA application for its ReActiv8 neuromodulation therapy for chronic back pain even though the ReActiv8 clinical trial failed to reach its primary endpoint.

ReActiv8
• Source: Mainstay Medical

Mainstay Medical International PLC believes it has enough data to move forward with a PMA application to US FDA for its ReActiv8 implantable spinal neuromodulator device to treat chronic back pain, even after its ReActiv8-B trial did not reach the primary endpoint in a key clinical trial.

In ReActiv8 B, a total of 204 patients were surgically implanted with the device at centers in the US, Europe,...

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