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.

Comments

  1. Kate Murphy says

    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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