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The Evoke system stimulates the spinal cord to lessen the effects of chronic pain in the trunk and limbs, including failed back surgery syndrome, intractable low back pain and leg pain, and continuously adjusts its therapy to optimize treatment. (Saluda Medical)
With the opioid epidemic still raging throughout the U.S., the scramble to find drug-free alternatives for chronic pain treatment continues. The latest candidate in that search comes from Saluda Medical and uses spinal cord stimulation—rather than prescription medication—to lessen the effects of intractable pain in the trunk and limbs.
Results of several studies of the closed-loop Evoke system have been so promising, in fact, that the FDA recently opted to approve the technology for chronic pain treatment. According to the company, this marks the first time the agency has handed down premarket approval to a spinal cord stimulation system based on the results of a double-blind, randomized controlled trial.
With the approval under its belt, the former Fierce 15 winner will begin a limited rollout of the system among several of its clinical trial sites in the second half of this year. A full commercial launch will follow in 2023.
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