Valencia’s eCoin for Urinary Urge Incontinence Gains FDA PMA

Privately-held Valencia Technologies Corporation earned U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its eCoin leadless tibial neurostimulator to treat urinary urge incontinence (UUI) which affects over 60 percent of those suffering from overactive bladder (OAB). According to the company, it’s the first tibial nerve stimulator implant approved by the FDA.
 
The eCoin nickel-sized stimulator is implanted subcutaneously just above the ankle over the tibial nerve in a minimally invasive, outpatient surgery with a local anesthetic. It contains a primary battery and once programmed automatically delivers intermittent stimulation to the tibial nerve, helping to reduce UUI symptoms.
 
eCoin doesn’t need ongoing power source management or a stepped program, in contrast to more invasive sacral neuromodulation surgery.
 
“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, founder of Valencia told the press. “eCoin will facilitate a paradigm shift for UUI treatments by offering physicians an efficient option for implantation with high patient satisfaction. The simplicity and effectiveness of eCoin will enable more patients to achieve the help they desperately need.”
 
A leadless design means no fragile wires to be precisely tunneled. A dome-shaped stimulation field helps calm the bladder and relieve bladder leakage.
 
“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 Dr. Rebecca McCrery, an Investigator in the eCoin pivotal trial. “Under 5 percent 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 133-patient trial data showed at least 50 percent UUI episode reduction in 75 percent of patients implanted with eCoin. 81 percent of patients reported feeling “better” to “very much better” one year following the procedure.
 
“eCoin is neuromodulation for the masses”, stated Dr. Scott MacDiarmid, investigator in the eCoin feasibility and pivotal trials. “Being the first leadless neurostimulator for bladder control is groundbreaking and paves the way for further applications.”
 
Valencia aims to launch eCoin this month and begin physician training in April.