Valencia Technologies said today it won FDA investigational device exemption approval to launch a pivotal trial of its eCoin neurostimulation device exploring its ability to treat overactive bladder.
The system, which is approximately the size of a nickel, is designed to implanted in a 10 minute procedure and send electrical impulses to the tibial nerve to stimulate the part of the brain that controls bladder response, the New York-based company said.
“There is great excitement for a therapy that delivers more than modest improvement in overactive bladder symptoms while avoiding the side-effects of drugs,” urologist Roger Dmochowski said in a press release.
The trial, which is slated to be conducted at 20 centers in the US, aims to explore whether the device is superior to the leading drug designed to treat overactive bladder, Valencia Technologies said.
“eCoin will change the way overactive bladder is treated because it is minimally invasive, has no side effects, and may prove to be superior in effectiveness to drugs and alternative therapies,” Valencia founder Jeff Greiner said in a prepared statement.
In October 2016, Valencia said it won investigational device exemption approval from the FDA to begin a trial of its eCoin neurostimulator for treating drug-resistant hypertension.
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