ConvaTec Introduces Flexi-Seal(R)(TM) SIGNAL(TM) FMS

SKILLMAN, N.J., Feb. 22 /PRNewswire/ -- ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, announced today the launch of Flexi-Seal®™ SIGNAL™ Fecal Management System (FMS).  Now available in the U.S., U.K. and other Key European markets, Flexi-Seal®™ SIGNAL™ FMS has been enhanced with key new features, including a 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.

Featuring the original innovative design that has made Flexi-Seal®™ FMS the most widely used fecal management system worldwide,(1) the new features for Flexi-Seal®™ SIGNAL™ FMS were designed to help reduce the risk of both skin breakdown and spread of infection, such as Clostridium difficile (C. difficile), improve patient care and comfort, as well as save nursing time and reduce total care costs.

"ConvaTec has made significant enhancements to Flexi-Seal®™ SIGNAL™ FMS based directly on clinician feedback, to help them achieve the greatest benefit for their patients," said Paul Moraviec, President, ConvaTec Continence & Critical Care.  "Specifically, clinicians wanted to know more about the fill status of the retention balloon inside the rectum.  The new signal indicator gives them that knowledge, and provides confidence that the balloon is filled for optimum performance."

The new signaling feature works as follows: Once the appropriate volume of fluid in the internal retention balloon has been reached, a small bubble pops out on the fill port, located on the external tubing.  When the indicator pops out and stays out, filing should stop, and should not exceed 45mL, to prevent over inflation.  Clinical observation has shown that proper inflation of the retention balloon minimizes the risk of leakage.

In addition to the signal indicator, Flexi-Seal®™ SIGNAL™ FMS enhancements include a new 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 new versatile strap has been designed to securely lock onto an open bed frame, also helping to minimize the risk of contamination that might result from spillage.  

Other new convenience and ease of use features include 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.

"Acute fecal incontinence has a major impact on the health and well-being of patients as well as caregivers, especially in the intensive care unit where it is prevalent and often associated with C. diff infection," said Marcus Schabacker, Chief Scientific Officer, ConvaTec.  "The addition of Flexi-Seal®™ SIGNAL™ FMS to our family of Flexi-Seal®™ fecal management systems provides an effective and innovative solution for clinicians managing fecal incontinence.  Flexi-Seal®™ SIGNAL™ FMS will set the new standard of care for the management of fecal incontinence and will help to further improve patient care."

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

Flexi-Seal®™ FMS, a 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.  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. Key features of Flexi-Seal®™ FMS include:

• A soft, low-pressure balloon designed to aid easy insertion and removal, and minimize the chance of tissue necrosis.
• A closed-end collection bag which may help reduce the spread of infection.
• An entirely latex-free design.

In October 2008, ConvaTec also introduced Flexi-Seal®™ FMS Advanced Odor Control, specifically designed to help manage severe odor* associated with fecal incontinence.  While maintaining all of the benefits of the original product, Flexi-Seal®™ FMS Advanced Odor Control has been shown to successfully eliminate* catheter odor permeation to levels below those that are humanly detectable.(3)

Clinical Evidence

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:(4)

• 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.

* Eliminates perceptible naphthalenic (indole) and sulfide odors radiating from the catheter tube.

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 business divisions – Ostomy Care, Wound Therapeutics, Continence and Critical Care, and Infusion Devices – ConvaTec products support health care professionals from the hospital to the community health setting. From its headquarters in Skillman, New Jersey, the company oversees more than 8,000 employees in over 90 countries serving consumers and their health care professionals on six continents. For more information, please visit www.convatec.com.

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

2. Use of filtered faecal collection bags to contain Clostridium difficile: an in vitro study. WHRI 3274 MA138. September 25, 2009. Data on file, ConvaTec.

3. Odor reduction in fecal management devices.  White Paper. 2009 Data on file, ConvaTec.

4. 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

Flexi-Seal is a registered trademark of ConvaTec Inc. in the U.S.

© 2010 ConvaTec Inc.

AP-009095-MM

SOURCE ConvaTec