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Vitala™ Pouchless Continence Control Device Shown to be Safe and Effective for up to 12 Hours in Phase 3 Clinical Trial
Date:9/28/2011

to wearing the device. No changes to stoma vascularity or gut microbiology were observed throughout the device wear stage.(1)

The majority of participants in the study found Vitala™ CCD easy to apply (76%), remove (99%) and dispose of (100%). More than four out of five users (83%) reported less odor than their usual device and three out of five (60%) said they experienced no noise while wearing Vitala™ CCD. The device was also reported to be comfortable by 94% of participants and its profile acceptable by 77% of participants.   At the end of the study period, approximately 70% of participants, who had used traditional pouching systems on average for more than six years, stated that they preferred Vitala™ CCD to their usual pouching system.(1)

"Vitala™ CCD was developed to give people with a colostomy regained control, more confidence and greater freedom, allowing them to feel much like they did before surgery," said Dheerendra Kommala, MD, Chief Medical Officer, ConvaTec. "In developing this novel technology, it was important to offer a high level of control with a device that is comfortable, safe, and able to manage noise and odor. The results of this clinical study provide further evidence that Vitala™ CCD truly represents a new era in ostomy care."

Vitala™ is currently available in the Czech Republic, Netherlands and the United Kingdom with additional introductions scheduled for Austria and Denmark.  Vitala™ CCD is recommended for use a minimum of six weeks after surgery.  Full product use information is available in the package insert.  For more information about Vitala™ CCD, please contact the ConvaTec customer information center.

About ConvaTecConvaTec is a leading developer and marketer of innovative medical technologies that have helped improve the lives of millions of people worldwide. With four key focus areas – Ostomy Care, Wound Therapeutics, Contine
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