/PRNewswire/ -- Uroplasty, Inc., a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today announced that the results of a long-term clinical pilot study using an implantable tibial nerve stimulation device will be presented at the Annual Meeting of the International Continence Society (ICS), October 15-19, 2012 in Beijing, China. Uroplasty acquired rights to the technology for this device when it acquired rights to its Urgent® PC product.
Urgent-SQ Implant in Treatment of Overactive Bladder Syndrome: Nine-Year Follow-up Study reviews the long term safety and durability of the device in seven patients who were implanted in 2003. Follow-up visits with the patients demonstrated that 3 of 7 have safely continued to use the device regularly over 9 years with sustained overactive bladder (OAB) symptom improvement and continued improvement in their quality of life. Another patient has successfully restarted using the device after participating in this follow-up study. There were no displacements or defects of the implants demonstrated on X-ray. All patients described the device as easy to handle.
"After nine years of clinical experience with an implanted subcutaneous tibial nerve stimulator, we have demonstrated that it is a durable therapy for treating OAB patients," said Professor John Heesakkers, Department of Urology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands. "We are pleased to report that many patients have sustained their OAB symptom improvement. Moreover we demonstrated that the device is very safe."
"There are several key advantages to an implantable tibial nerve stimulator," said David Kaysen, Uroplasty CEO and President. "This device allows the patients to continue therapy at home according to the schedule that works best for them using a very low profile device that appears to have few if any adverse events. 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. 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.