ConvaTec's Vitala(TM) Continence Control Device Receives 510(K) Clearance From FDA

SKILLMAN, N.J., April 9 /PRNewswire/ -- ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market Vitala(TM), an exceptionally innovative, non-intrusive ostomy continence control device, for people with an end colostomy.

This innovative pouchless ostomy device functions by sealing against the stoma to prevent 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. The unique design of Vitala(TM) not only eliminates the need for a pouch for an extended period of time each day, it also minimizes the noise and odors that sometimes accompany pouch use. The device's discreet low profile also helps make the presence of an ostomy less noticeable.

A Phase II clinical trial has shown that the Vitala(TM) Continence Control Device is safe for use, up to 8 hours.(1) Vitala(TM) is recommended for use 6-12 weeks after surgery. Full product use information will be available in the package insert.

Currently available in select European markets, Vitala(TM) will be previewed to U.S. and global healthcare professionals at the upcoming WOCN/WCET Joint Meeting in Phoenix, AZ from June 12-16, 2010. Vitala(TM) will be introduced in the United States a few months after the meeting.

For more information about the Vitala(TM) Continence Control Device, please contact the ConvaTec customer information center at 1-800-422-8811.

(C) 2010 ConvaTec Inc AP-009552-US

CONTACT: Punnie Donohue, ConvaTec, +1-908-904-2151,
punnie.donohue@convatec.com, or Liz True, Weber Shandwick, +1-212-445-8481,
ltrue@webershandwick.com

Web site: http://www.convatec.com/