ConvaTec Introduces Flexi-Seal(TM) SIGNAL(TM) FMS
By Convatec, PRNEMonday, June 21, 2010
A new solution from the Flexi-Seal(TM) FMS family of fecal management systems that helps clinicians seal their patients' protection
SKILLMAN, New Jersey, June 23, 2010 - ConvaTec, a world-leading developer and marketer of innovative medical
technologies for community and hospital care, announced today the launch of
Flexi-Seal(TM) SIGNAL(TM) Fecal Management System (FMS). Now available in
several key European markets, Flexi-Seal(TM) SIGNAL(TM) 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(TM) FMS
the most widely used fecal management system worldwide,(1) the new features
for Flexi-Seal(TM) SIGNAL(TM) 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(TM) SIGNAL(TM)
FMS based directly on clinician feedback, to help them achieve the greatest
benefit for their patients," said Nino Pionati, President, Global Marketing
and Business Development. "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(TM) SIGNAL(TM) 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(TM) SIGNAL(TM) FMS to our family of Flexi-Seal(TM) fecal
management systems provides an effective and innovative solution for
clinicians managing fecal incontinence. Flexi-Seal(TM) SIGNAL(TM) 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(TM) FMS family of fecal management systems
Flexi-Seal(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) FMS in subjects with liquid or
semi-liquid diarrhea and incontinence. Key findings include:(4)
- Rectal mucosa was healthy after Flexi-Seal(TM) 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(TM) 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.
(c) 2010 ConvaTec Inc. AP-009095-MM
Media Contacts: Amy Firsching Etanjalie Ayala ConvaTec Weber Shandwick +1-908-904-2088 +1-212-445-8255 Amy.Firsching@convatec.com eayala@webershandwick.com
Amy Firsching, ConvaTec, +1-908-904-2088, Amy.Firsching at convatec.com; or Etanjalie Ayala, Weber Shandwick, +1-212-445-8255, eayala at webershandwick.com
Tags: ConvaTec, Europe, June 22, June 23, new jersey, Russia, Skillman