Mainstay Medical Reaches Milestone With Interim Results Of US Clinical Trial
Mainstay Medical is making steps towards the US commercialization of its neurostimulation system ReActiv8. The company announced a positive outcome from interim analysis of its US ReActiv8 B clinical trial which aims to gather data in support of an application for pre-market approval from the US FDA.
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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.
While demand for spinal cord stimulation (SCS) devices used in pain management continues to expand at double-digit rates, a small but growing number of highly innovative companies that develop stimulators to specifically target peripheral nerve pain is creating excitement among pain doctors looking for better options to treat an intractable population that's seen little success with standard therapy. With millions of people worldwide suffering from low back pain, severe headaches and migraines, neck pain and other chronic pain, the demand for safe, effective, percutaneously-placed devices remains high. In this article, we'll highlight emerging companies working on PNS devices and provide insights from pain physicians on the pros and cons of these devices.