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New Surinate Catheters for Men Granted IDE Approval by the FDA
Filed Under (Catheter Information, Product Reviews) by admin on 29-03-2010
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The New Jersey-based UroValve has been granted Investigational Device Exemption (IDE) approval for their product, the Surinate Bladder Management System, which means clinical studies will begin according to this Press Release from Urovalve.
Surinate is an ingenious urinary catheter designed for men who suffer from urine retention. Urine retention can be caused from a number of conditions in aging men, the most common being enlarged prostates (BPH) which create urine retention, urge incontinence, and overactive bladder issues.
Many men try drugs, incontinence products such as diapers and external catheters to help manage episodes. Men who can’t do these – or choose not to – will suffer through intermittent catheterization up to 6 times a day to drain their bladder.
The Surniate Catheter isn’t just a catheter, it’s actually a valve system that is far superior to other catheters on the market for these men. Here’s why:
Surniate keeps an open flow from the bladder to the external sphincter (just below the prostate) with a valve system easily controlled with an external magnet. The catheter valves keep the flow turned off until the wearer uses a small magnet externally to “switch” the valve’s position internally, just below the prostate, allowing the urine to flow out. When the magnet is pulled away, the valve shuts again and prevents the urine from flowing out.
The Advantages
- Less catheterization – The Surniate valve system can be work up to 28 days before replaced, as opposed to 4-6 times per day with traditional Intermittent/Foley catherers.
- Easier to Drain – The device allows one to function like normal; scheduling bathroom times and easily draining the bladder without unnecessary cathing and risk of UTIs and unnecessary discomfort.
To find out more about this new technology now undergoing clinical trials including a video, see Urovalve’s Technology page.
