FDA grants IDE approval for Urovalve's Surinate Bladder Management System

Urovalve, a medical device company focused on creating superior products for urinary flow and control, announced today that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for the Company's Surinate® Bladder Management System, allowing Urovalve to conduct a clinical study for the Company's lead device in the United States.

“For example, Surinate® is designed so that a patient is no longer coupled to a urine-collection bag on his leg, so no one has to know that the patient has a urinary retention condition. Equally important”

The Surinate® Bladder Management System is designed to improve the quality of life of men who suffer from acute or chronic urinary retention, an inability to empty the bladder.

"This is a big step forward for Urovalve, and we expect to commence the clinical study very soon," said Harvey D. Homan, Ph.D., President and CEO of Urovalve, who was recently appointed to the National Institutes of Health's Center for Scientific Review special emphasis panel for Urology and Small Business.

"There is a dire need in healthcare for Surinate®. The fact is that, today, men who have a urinary retention condition have to rely on a 50-year-old product called the Foley catheter, or they must suffer through intermittent catheterization four to six times a day. Fortunately, Surinate® is designed to have several critically important advantages not only compared to the half-century-old product but also compared to the inconvenient products on the market today," said Dr. Homan.

"For example, Surinate® is designed so that a patient is no longer coupled to a urine-collection bag on his leg, so no one has to know that the patient has a urinary retention condition. Equally 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. Plus, the Surinate® valved catheter is designed to remain in the patient for up to 30 days. In short, with Surinate® the patient himself has total control over his bladder-emptying process."