No-Pouch Colostomy Appliance Approved

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.

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