No-Pouch Colostomy Appliance Approved

Posted by Kate Murphy on April 12th, 2010

A new appliance that eliminates the need for ostomates to wear an external pouch has received pre-marketing approval by the FDA.

Expected to be on the US market in the next few months. the Vitala™ device, seals the stoma, preventing stool from leaving the body for up to 8 hours. Intestinal gas is filtered and vented to prevent odor.

An external pouch will still be needed for wear longer than 8 hours.

The Vitala Continence Control Device has a built-in expandable container permitting removal without risk of soiling. It is waterproof and can be worn during bathing or swimming.

People with colostomies can begin to use the device 6 to 12 weeks after surgery.

ConvaTec was granted 501(K) clearance to market Vitala from the FDA on April 9,2010.

Tags: colostomy, ostomies Comments (2): Add a comment

2 Responses to “No-Pouch Colostomy Appliance Approved”

April 13, 2010 at 9:32 am, Robert W. Simson said:

I am interested in getting more information about the appliance

thank you
April 13, 2010 at 10:53 am, Kate Murphy said:

The appliance is not yet on the market in the US, so information is not easily available yet.

We’ll be watching for it.

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