This did not stop Mainstay’s chief executive, Jason Hannon, from comparing the Reactiv8 response rates to those seen with the older devices. In addition, Reactiv8 is intended for patients who have not had back surgery, while traditional SCSs can be used in those with failed back surgery. ![]() It is designed to stimulate the nerves that activate the muscles that stabilise the lower back, while conventional SCSs are designed to mask pain by blocking pain signals before they reach the brain. Reactiv8 works differently from these existing devices, however. Selected spinal cord simulation franchises The company is pinning its hopes on an apparently improving response to Reactiv8 therapy over time, as well as an unmet need in back pain, but the jury is out on whether this will be enough to convince the agency.įor one, several other spinal cord stimulators (SCSs) are already approved in the US for back pain, including offerings from big hitters like Medtronic, Abbott and Boston Scientific, as well as the Senza system from Nevro. Investors appeared to agree, sending the group’s stock down 37% this morning. ![]() It put a brave face on the failure of a trial designed to support US approval of its Reactiv8 neurostimulator for chronic low back pain, but getting the FDA go-ahead now looks like a long shot. ![]() Mainstay Medical is not the first medical device company to be hit by an unexpectedly positive response in a sham control group.
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