Studies Demonstrate Safety, Efficacy and Benefits of Vitala™ Pouchless Continence Control Device

BOLOGNA, Italy, June 15, 2011 /PRNewswire/ --

Presented at 11th Congress of the European Council of Enterostomal Therapy (ECET)

Colostomy patients using the Vitala™ Continence Control Device (CCD) reported high levels of restored continence, functional and psychosocial benefits, according to the findings of clinical and case studies presented at the 11th Congress of the European Council of Enterostomal Therapy (ECET) in Bologna, Italy.(1,2)

Developed by ConvaTec, Vitala™ CCD is an innovative, non-invasive device that restores continence for up to 12 hours per day, allowing individuals to manage their colostomy without having to wear a pouch or incorporate irrigation.  When in use, Vitala™ CCD prevents the uncontrolled release of stool, which is stored inside the body, while permitting gasses to vent through an integrated, deodorising filter. (3)

"Colostomy patients face many functional issues that can profoundly impact their psychological health, professional and social interaction, and quality of life," said lead study investigator Terri Maxwell, RN, MSN, BC-FNP-C, CWOCN. "These findings further validate the results of our earlier clinical trial with Vitala™ CCD, adding to the evidence base and extending the benefits of this transformative technology to people with a colostomy."

In a Phase 3, multi-centre clinical study, the safety and efficacy of Vitala™ CCD was evaluated when worn up to 12 hours a day by individuals with an end colostomy. Participants in the study (n=78) were monitored across treatment stages: usual pouching (21 days), skin barrier transition (14 days), and device wear (21 days of device ramp-up increasing to 12 hours of daily wear for 159 days).

After the study period of 215 days, results showed that there were two serious adverse events possibly related to wearing the device (bruising of peristomal skin which was resolved).  No changes to stoma vascularity were observed throughout the device wear stage.  Participants in the study reported high levels of satisfaction with Vitala™ CCD and its performance, with 87 percent rating the ability of the device to restore continence as good or very good.  More than four out of five users (83 percent) reported less odour and three out of five (60 percent) said they experienced no noise when wearing Vitala™ CCD.  At the end of the study period, 70 percent of participants stated that the Vitala™ device was their preferred stoma care system. (1)

At the meeting, ConvaTec also presented the results of an additional clinical study evaluating the safety and efficacy of Vitala™ CCD in people with an end colostomy who require convex skin barriers or inserts. In this study, 27 participants with an end colostomy, including 14 patients with a stoma that does not protrude, used Vitala™ CCD, increasing daily wear time up to 12 hours over 29 days. (2)

"Vitala™ CCD has been remarkably well received by European stoma patients.  The findings from these new studies provide substantial additional support that this technology represents an historic advance in ostomy care," said Dheerendra Kommala, Chief Medical Officer of ConvaTec. "The ability to help stoma patients regain continence control and more confidence represents a major advance in care, and we are hearing from people around the world that Vitala™ CCD does just that. Many individuals report that the 12 hours of continence that Vitala™ CCD provides has had a major positive impact on their lives."

Vitala™ CCD is a single-use, disposable disc-shaped device that is worn together with the ConvaTec Natura® skin barrier (flat, convex or with convex inserts) and comes in two sizes (45mm and 57mm).   Currently available in the Netherlands, Czech Republic and United Kingdom, Vitala™ CCD is soon to be launched in additional European markets.

About ConvaTec

ConvaTec 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, Continence and Critical Care, and Infusion Devices - ConvaTec products support healthcare professionals from the hospital to the community health setting. For more information, please visit http://www.convatec.com.

Vitala is a trademark of ConvaTec Inc.

Natura is a registered trademark of ConvaTec Inc.

© 2011 ConvaTec Inc.

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(1) Transforming Ostomy Care: Restoring Patients' Colostomy Continence and Quality of Life.  Symposia presented at 11th Congress of the Council of Enterostomal Therapy (ECET); June 12-15, 2011; Bologna, Italy.

(2) Maxwell, TR. Clinical study of the Vitala™ Continence Control Device (CCD) in combination with convex products. Poster presented at 11th Congress of the European Council of Enterostomal Therapy (ECET); June 12-15, 2011; Bologna, Italy.

(3) Multinational Phase III Vitala™ CCD 12-Hour Wear Test. CC-0196-08-A720. June 18, 2010, Data on file, ConvaTec Inc.

   
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