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.