Valencia Technologies Corporation has announced that the US Food and Drug Administration (FDA) has granted premarket approval of its eCoin leadless tibial neurostimulator for the treatment of urinary urge incontinence (UUI)—which affects more than 60% of patients who suffer from overactive bladder (OAB), a company press release states.
FDA approval was supported by the efficacy and favourable safety profile demonstrated in the eCoin pivotal trial. The company has also published these results in the Journal of Urology.
“Beyond delivering impressive results achieved without the need for prior screening, the eCoin procedure is easily understood by patients, reproducible amongst physicians, and accomplished in a safe and effective manner,” said Rebecca McCrery (CHI Health Lakeside, Omaha, USA), an investigator in the eCoin pivotal trial. “Under 5% of OAB patients select burdensome third line interventions due to invasiveness or potential side-effects of available therapies and limitations in access, resulting in a staggering unmet clinical need. The effortless relief provided by the automatic nature of eCoin neuromodulation therapy will potentially better treat the vast population—often desperate for relief—who are not well managed by the current options available to them.”
The eCoin device is a nickel-sized neurostimulator that is implanted subcutaneously in the lower leg during a minimally invasive outpatient procedure utilising a local anaesthetic. According to Valencia Technologies, eCoin is the first implantable tibial nerve stimulator approved by the FDA. The device contains a primary battery and, once programmed, automatically delivers intermittent stimulation to the tibial nerve to reduce UUI symptoms.
The device does not require ongoing patient management of a power source or a stepped programmer, and the therapy is clinically different from more invasive sacral neuromodulation surgery—which typically requires general anaesthesia after a testing period as well as ongoing patient device management, the release adds.
The design of the eCoin implantable device is leadless, meaning there are no fragile wires that need to be precisely tunnelled to reach the intended nerve for therapy, according to Valencia Technologies. Instead, the eCoin device is implanted just above the ankle over the tibial nerve and its forgiving, dome-shaped stimulation field delivers regular stimulation to the nerve to calm the bladder and provide relief from bladder leakage.
“eCoin is neuromodulation for the masses,” said Scott MacDiarmid (University of North Carolina School of Medicine, Chapel Hill, USA), investigator in the feasibility and pivotal trials of the eCoin device. “Being the first leadless neurostimulator for bladder control is groundbreaking and paves the way for further applications.”