ConvaTec Introduces Enhanced Flexi-Seal® SIGNAL® FMS

SKILLMAN, N.J., June 12, 2012 /PRNewswire/ -- ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, announced today the launch of enhanced Flexi-Seal® SIGNAL® Fecal Management System (FMS). 

Already available in Canada and now in the U.S., Flexi-Seal® SIGNAL® FMS has been enhanced with nurse-inspired features to respond to clinicians' needs.

In addition to the original innovative design and SIGNAL™ indicator, Flexi-Seal® SIGNAL® FMS enhancements include:

• A sampling port designed for safe and easy stool collection and to help decrease risk of exposure to infectious stool
• A simple medication delivery process to allow prescribed medication rectally via the irrigation port, without complicating the use of the device
• An extended catheter that adapts to a range of bed sizes and accommodates a variety of patient heights and weights

About the Flexi-Seal® FMS family of fecal management systems

Flexi-Seal® FMS is used by more nurses and hospitals than any other fecal management system in the world.(1)

Flexi-Seal® FMS is indicated for patients with little or no bowel control and liquid or semi-liquid stool, and can be used for up to 29 consecutive days. This temporary containment device for patients with acute fecal incontinence was designed to safely and effectively divert fecal matter, protect patients' wounds from fecal contamination, and reduce the risk of skin breakdown and spread of infection. 

Other key features of Flexi-Seal® SIGNAL® FMS include:

• Unique SIGNAL™ indicator that pops to assist clinicians in determining when the device's retention balloon is filled to an appropriate volume -- providing confidence that the product is filled for its optimum performance -- thus creating a safe and effective seal for their patients' protection.*
• A soft, low-pressure balloon designed to aid easy insertion and removal and minimize the chance of tissue necrosis.
• A closed-end charcoal-filtered collection bag which is designed to contain and lock in odor, and provides an effective barrier to C. difficile transmission, thus helping to minimize the risk of cross-contamination.(2)  
• A blue, easy to locate finger pocket designed for simple single-finger insertion and an increased irrigation lumen to aid in the administration of fluid to facilitate irrigation.
• A versatile strap designed to securely lock onto an open bed frame, also helping to minimize the risk of contamination that might result from spillage. 
• Does not contain natural rubber latex components.

Clinical Evidence

Flexi-Seal® SIGNAL® FMS has been scientifically proven in vitro to contain the spread of C. difficile.(2)

A prospective, 42-patient clinical study was conducted to evaluate the safety and performance of Flexi-Seal® FMS in subjects with liquid or semi-liquid diarrhea and incontinence. Key findings include:(3)

• Rectal mucosa was healthy after Flexi-Seal® FMS use for all patients who had baseline and follow-up endoscopy.
• 92% of patients had their skin condition maintained or improved.
• 83% of caregivers reported that Flexi-Seal® FMS improved fecal incontinence control, was efficacious, and time efficient.

* Signal indicator could pop before 45mL if the space available for the balloon is smaller than the balloon. Filling should stop when the indicator pops out and stays out. More than 45mL is never to be added to the balloon.

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 www.convatec.com.

(1) HPIS. Q2 2009. Moving Annual Total (MAT) Fecal Control Category. Data on file, ConvaTec.

(2) Jones S, Towers V, Welsby S, Wishin J, Bowler P. Clostridium difficile Containment Properties of a Fecal Management System: An In Vitro Investigation. Ostomy Wound Management, 2011;57(10):38-49.

(3) Padmanabhan A, Stern M, Wishin J, Mangino M, Richey K, DeSane M. Clinical evaluation of a flexible fecal incontinence management system. Am J Crit Care, July 2007;16:384-393.

®/™ indicates trademarks of ConvaTec Inc.

© 2012 ConvaTec Inc.                                                                                         

SOURCE ConvaTec