Valencia Technologies this week updated on the pivotal trial of its eCoin overactive bladder neurostim device, saying it has enrolled more than 35 patients and that it expects to finish implantations by January next year, with a hopeful completion date of January 2020.
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.
The single-arm pivotal trial, which won approval by the FDA in March, aims to enroll a total of 120 patients across 19 centers in the US, with procedures performed half in procedure rooms and half in office settings, according to a chief administrative officer Stacy Chambliss.
Valencia will look to file its FDA premarket approval application shortly after the trial is completed, Chambliss told MassDevice.com in an email.
“Based on feedback from the pivotal study investigators, we think patients who previously chose Botox or Interstim will want eCoin, and many more patients who previously declined those invasive therapies will choose eCoin,” Chambliss wrote.
Also this week, the Los Angeles-based company said it published data from a 46-patient feasibility study of the eCoin device in the Journal of Urology.
Data from the study indicated a 70% responder rate at the three month primary endpoint, indicating 70% of patients experienced at least a 50% improvement in their urgency urinary incontinence symptoms. Results also indicated that 22% no longer experienced UUI, durable through to six months.
“These results are more than encouraging. It appears that eCoin delivers similar efficacy to the other treatments without the side effects of drugs or Botox, without the invasiveness of sacral nerve stimulation, and without the patient compliance issues of percutaneous tibial nerve stimulation,” lead author and investigator Dr. Scott MacDiarmid said in a press release.