FDA grants 510(K) clearance to market Vitala Continence Control Device

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.

"For people with a colostomy, Vitala™ will provide a new benchmark in ostomy management, giving them regained control, more confidence and greater freedom than ever before," said Nino Pionati, President of ConvaTec Ostomy Care.  "This clearance represents a true milestone for ConvaTec and a significant leap forward for the customers we serve.  Their needs inspired us to develop this breakthrough technology, to make a difference in people's lives."

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

Easy to apply and remove, the Vitala™ Continence Control Device contains a built-in expandable container to prevent soiling and odor during the removal process.  Vitala™ is also waterproof, so it can be worn when bathing, showering or swimming.

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.

"Since ConvaTec first introduced ostomy appliances more than three decades ago, we have continually focused on finding new and better ways to help patients return to a full life after surgery," added Pionati.  "Today, with Vitala™, we believe a new era in ostomy management is ready to begin."

Source:

ConvaTec

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