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Valencia Technologies announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin® tibial neurostimulator to treat urinary urge incontinence (UUI). UUI, affecting over 60% of patients who suffer from Overactive Bladder (OAB), occurs when the detrusor muscle surrounding the bladder contracts inappropriately during the filling stage, leading to the unintentional loss of urine. eCoin® is a leadless, nickel-sized neurostimulator implanted under the skin in the lower leg. It contains a primary battery that, once programmed, reduces UUI symptoms by automatically delivering intermittent stimulation to the tibial nerve. It is the first and only implantable tibial nerve stimulator approved by the FDA. Unlike sacral neuromodulation surgery, insertion of the eCoin® can be performed as a minimally invasive, outpatient procedure utilizing a local anesthetic, and the device does not require ongoing patient management of a power source or a stepped programmer. Valencia Technologies is a neuromodulation company founded upon a plan to create, develop, and manufacture electroceuticals for bladder dysfunction and other chronic conditions.

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