Uroplasty has reported positive results from subcutaneous tibial nerve stimulator's nine-year follow-up study.
The FDA-approved stimulator, Urgent PC neuromodulation system, is a minimally invasive device used for treating overactive bladder (OAB) syndrome and symptoms of urinary urgency, urinary frequency and urge incontinence.
The pilot study involved seven patients, who were implanted in 2003, to assess the safety and durability of the device.
The results demonstrated that three of seven patients have continued to use the device and improvements were observed in sustained OAB symptom and their quality of life.
Uroplasty CEO and president David Kaysen said that a low profile nerve stimulator that appears to have few adverse events allows patients to continue their therapy at home.
"Based upon these promising results, Uroplasty has begun a Research and Development initiative to bring a version of this implantable tibial nerve neuromodulation device to the market," Kaysen added.
"As we announced previously, we plan to first acquire a CE mark and commercialize the device in Europe before starting the regulatory process in the United States.
"Patients will receive their initial therapy with the Uroplasty Urgent PC Neuromodulation System before being offered the option of an implant."
