Tag Archive | "bladder management"

Urovalve’s Surinate Bladder Management System Passes Feasibility Study

The company Urovalve recently announced the successful results of a feasibility study on the Valve component of their new Surinate Bladder Management system. The product is designed to improve the quality of life of men who experience acute or chronic urinary retention, which is an inability to empty the bladder due to an obstruction of the urethra.

“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,” explained Harvey D. Homan, Ph.D., President and CEO 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 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. Bottom line? 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.”

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Potential Success for Surinate Bladder Management System

According to a recent study pertaining to the efficacy of the Surinate Bladder Management System, the device has proven successful in thirteen of the first fourteen subjects tested.  The product was created by Urovalve, a medical device company focused on creating superior products for urinary flow and control.  Specifically, the company has created Surinate to improve the quality of life and health of men who suffer from acute or chronic urinary retention, which is the inability to empty the bladder.

The multi-site clinical study of the Surinate included proper insertion of the device into thirteen subjects.  All 13 experienced proper position of the system and were able to correctly use it to empty their bladder successfully for more than 24 hours.  On average, the Surinate device remained in place for about 14.1 days until the final visit and removal.  No irritation or injury to the urethra has been reported in the 13 subjects; however, mild irritation of the bladder was observed cystoscopically in two subjects upon removal of the catheter.  In addition, one patient with spinal cord injuries formed bladder stones, which is one of the common problems associated with the competing Foley catheters in spinal cord patients.

“These early clinical results are extremely encouraging,” said Harvey D. Homan, Ph.D., president and CEO of Urovalve.  “What we need to see going forward is patients who are able to have the Surinate catheter remain in place for 30 consecutive days.  We are confident that we will reach this important endpoint in the study.”

Before the Surinate was developed, patients with urinary retention conditions had to rely on a 60-year-old product called a Foley catheter connected to a collection bag.  The other option was to suffer through intermittent catheterization four to six times a day in order to urinate.  Urovalve researchers and producers feel that an updated product in healthcare was necessary, and Surinate seems to be the answer.

The benefit of Surinate relies on its ability to eliminate the need for a urine-collection bag or the discomfort of intermittent catheterization.  The Surinate contains an internal magnetic valve within the catheter that allows the bladder to fill and then empty at the command of the patient.  The patient manually uses an external magnet to open the valve in the catheter to drain the bladder when he needs to.  The Surinate catheter is designed to remain in the patient for up to 30 days.  Proponents of this new device stress its design to allow the patient complete control over his bladder-emptying process and believe it to be an important step toward increasing quality of life for men who have urinary retention problems.

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