Research & Development
Valencia wins US FDA approval for pivotal clinical trial of new eCoin technology for overactive bladder
12 March 2018 -

Medical technology company Valencia Technologies Corporation reported on Friday the receipt of approval from the US FDA to conduct a pivotal clinical trial using the new eCoin technology for the treatment of overactive bladder.

According to the company, the eCoin works by sending out electrical impulses to the tibial nerve which takes these signals to the part of the brain that controls bladder response. The device is about the size of a US nickel and is implanted in a ten minute in-office procedure. The physician who cares for incontinence patients, a urologist or urogynecologist, does the procedure under local anesthetic.

Valencia added that the pivotal clinical trial the new eCoin technology will be conducted at 20 different medical centres throughout the US.

The protocol approved by the US FDA shows Valencia will attempt to prove that its device produces superior effectiveness to the published results of a leading drug. If proven, patients will have an effective alternative to drugs currently on the market - without side-effects.

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