ConvaTec’s Vitala Continence Control Device Receives FDA OK

ConvaTec out of Skillman, NJ announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market Vitala, an innovative, non-intrusive ostomy continence control device for people with an end colostomy.
The Vitala Continence Control Device allows individuals to manage their colostomy without a pouch, belt or irrigation. A Phase II clinical trial has shown that the device is safe for use up to 8 hours, and is recommended for use 6-12 weeks after surgery. It functions by sealing against the stoma to prevent the release of stool while permitting gasses to vent through an integrated, deodorizing filter. When in use, stool is stored inside the body, negating the need to wear an ostomy pouch.
Press release: Vitala(TM) Continence Control Device Receives 510(K) Clearance From U.S. Food and Drug Administration…