Vitala(TM) Continence Control Device Gets 501(K) Approval from FDA – Big News for Those Who Have Had Colostomy – Qua
Posted Apr 12 2010 11:30am
This is a product and subject that perhaps many don’t like to talk about, but for 8 hours an individual who now wears a patch has the opportunity for a few hours to go without as it is stored inside the body and released later. When I say quality of life, the odors and noise that people who wear a pouch can tell you about is also a great enhancement, just ask someone who had had the procedure and how they feel.
The device has already been cleared and in use in Europe. The device can be worn as long as 8 hours, so that can get a person through most of the day too. BD
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™, an exceptionally 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. Indicated for use up to 8 hours, Vitala™ is a single-use, disposable disc which is worn together with the ConvaTec Natura® skin barrier (1-3/4" or 2-1/4").
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™ 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.
Currently available in select European markets, Vitala™ 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™ will be introduced in the United States a few months after the meeting.