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Thursday, May 23, 2024

FDA Approves Valencia Technologies’ Neurostimulator

Valencia Technologies has received U.S. Food and Drug Administration premarket approval for its eCoin, a leadless neurostimulator for the treatment of urinary urge incontinence.

The condition, also called UUI, is the loss of bladder control, with symptoms such as experiencing occasional or minor leaks. According to Valencia Technologies, the condition affects more than 60 percent of patients who suffer from overactive bladder.

The eCoin, which delivers intermittent stimulation to the tibial nerve to reduce UUI symptoms, is implanted in the lower leg in a minimally invasive procedure. The device’s leadless feature means no wires have to be tunneled to reach the intended nerve for therapy.

“This is a landmark approval for physicians and UUI patients as eCoin is now the first and only implantable tibial nerve stimulator approved by the FDA,” Jeff Greiner, Valencia Technologies’ founder, said in a statement. “eCoin will facilitate a paradigm shift for UUI treatments by offering physicians an efficient option for implantation with high patient satisfaction.”

The Valencia-based company expects to launch eCoin commercially this month with physician training beginning in April.

Antonio Pequeño IV
Antonio Pequeño IV
Antonio “Tony” Pequeño IV is a reporter covering health care, finance and law for the San Fernando Valley Business Journal. He specializes in reporting on some of the biggest names in the Valley’s biotechnology sector. In addition to his work with the Business Journal, Tony has reported with BuzzFeed News on the unsupervised use of Clearview AI, a controversial facial recognition technology. Tony, who also conducts freelance reporting, graduated from the USC’s Master of Science in Journalism program in 2021. He is in his fifth year as a journalist as of 2021.

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