Urovalve, Inc. (Urovalve), has successfully completed the feasibility trial for valve component of its Surinate Bladder Management System. The system is intended for men who suffer from acute or chronic urinary retention.
The feasibility study was designed to evaluate whether the beta version of the Surinate Valve is safe and functional in a real-use situation (i.e., when attached in line with a Foley catheter) and to provide information to guide the design of future clinical studies. This feasibility study was reviewed and approved by an IRB (Investigational Review Board) for each of the investigational sites as a non-significant risk (NSR) study. Therefore, an IDE (Investigational Device Exemption) application did not need to be submitted to, or approved by, the FDA. The target indication for the eventual marketed System will be for controlled urinary drainage in male subjects. However, the purpose of this feasibility study was to assess the performance only of the Valve (which is one component only of the eventual marketed device) and not of the entire System.
“Today, men who have a urinary retention condition must rely on a 50-year-old product called the Foley catheter, or intermittent catheterization four to six times a day,” said Harvey D. Homan, Ph.D., president and chief executive officer of Urovalve. “Surinate is designed so that the patient is no longer coupled to a urine-collection bag on his leg, which means of course that no one has to know that the patient has a urinary retention condition.
“Just as important,” added Dr. Homan, “is the fact that Surinate is designed with a magnetized valve inside the catheter that allows the bladder to fill and then empty only on command of the patient. In addition, the patient uses an external magnet to open the valve in the Surinate catheter to drain the bladder only when he needs to. The patient himself has total control over his bladder-emptying process.
“This successful feasibility study has provided valuable information regarding the design and use of the beta version of the Surinate Valve, which will be incorporated into future clinical evaluations,” Dr. Homan explained. “The most significant of these findings were, first, that the Valve’s performance exceeded specifications, second, that encrustation does not appear to be a significant problem affecting the Valve’s performance, and third, that leaching of samarium or cobalt does not appear to occur, nor does it pose a significant risk to subjects. With these results, we look forward to announcing commencement of a pilot study of the beta version our of complete Surinate system before year-end.”