ConvaTec Introduces Flexi-Seal(R) FMS Advanced Odor Control

* Reuters is not responsible for the content in this press release.

Thu Oct 23, 2008 10:00am EDT

Improved Control for Odor Associated with Fecal Incontinence

SKILLMAN, N.J., Oct. 23 /PRNewswire/ -- ConvaTec, a world-leading developer
and marketer of innovative medical technologies for community and hospital
care, announced today the availability of the Flexi-Seal(R) Fecal Management
System (FMS) Advanced Odor Control. The new Flexi-Seal FMS Advanced Odor
Control is specifically designed to help manage odor* associated with fecal
incontinence.

The new Flexi-Seal(R) FMS Advanced Odor Control manages odor in two distinct
ways: first, the new nylon inner odor barrier HOLDS the odor molecules within
the silicone catheter(1); second, the device contains a charcoal filter in the
collection bag that deodorizes gas as it is released. In a comparative
laboratory testing, Flexi-Seal(R) FMS Advanced Odor Control was shown to
successfully eliminate* catheter odor permeation to levels below those that
are humanly detectable. Parylene-coated silicone catheters do not effectively
manage odor.(1)

"As the leader in helping clinicians manage acute fecal incontinence, ConvaTec
is meeting an important unmet need in this vital area of critical care," said
Marcus Schabacker, Chief Scientific Officer, ConvaTec Inc. "In addition to
promoting skin integrity and reducing the risk of infection spread, the new
Flexi-Seal(R) FMS Advanced Odor Control is designed to provide a more pleasant
environment for both patients and their caregivers."

The innovative Flexi-Seal(R) FMS was designed to safely and effectively divert
fecal matter, protect patients' wounds from fecal contamination, and reduce
the risk of both skin breakdown and spread of infection, such as
Clostridiumdifficile (C difficile). Flexi-Seal(R) FMS Advanced Odor Control
retains all of the original product benefits and is used exactly the same way
as the current Flexi-Seal(R) FMS.

"The level of odor associated with fecal incontinence can vary considerably
from patient to patient, with its cause often difficult to fully identify and
manage," said Mary Webb RN, BSN, MA, CIC, Infection Control Preventionist, San
Mateo Medical Center, San Mateo, CA. "In these situations, the new
Flexi-Seal(R) FMS Advanced Odor Control can be extremely beneficial to both
clinicians and patients, providing a safe and effective option for containing
and managing odor."

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

About Fecal Incontinence and Pressure Ulcers

As the U.S. Centers for Medicare and Medicaid Services (CMS) institutes
reimbursement reforms for hospital-acquired pressure ulcers this month, many
U.S. hospitals are implementing pressure ulcer prevention guidelines and
seeking systems and devices that can help prevent pressure ulcer
development.(2) The management of fecal incontinence, a risk factor in the
development of pressure ulcers and the transmission of nosocomial infections,
is a priority in acute and critical care hospital settings.(3) Pressure
ulcers, which are among the most prevalent forms of chronic wounds, were
reported in approximately 10-18 percent of acute-care settings in the United
States between 1990 and 2000.(4)

About Flexi-Seal(R) FMS 

Flexi-Seal(R) FMS is a temporary containment device indicated for patients
with little or no bowel control, and can be used for up to 29 consecutive
days. Unique features of Flexi-Seal(R) 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.
    --  A unique, patented finger pocket guides easy insertion.
    --  An entirely latex-free design.



Clinical Evidence

A prospective, 42-patient clinical study was conducted to evaluate the safety
and performance of the Flexi-Seal(R) FMS in subjects with diarrhea and
incontinence. Key findings include(5): 

    --  Rectal mucosa was healthy after Flexi-Seal(R) 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(R) FMS improved fecal
        incontinence control, was efficacious, and time efficient.



To date, Flexi-Seal(R) FMS is the number one brand in unit sales to
distributors(6), and is being widely used at over 1,800 intensive care unit
hospitals(7) in the United States. ConvaTec continues to support healthcare
professionals with a dedicated on-call nurse specialist program. Over 110,000
nurses have been trained on Flexi-Seal(R) FMS(8).

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.

(C) 2008 ConvaTec Inc.
Flexi-Seal is a registered trademark of ConvaTec Inc.
Our world is what we make of it is a trademark of ConvaTec Inc.

AP-005973-US

References:
(1) Odor Reduction in Fecal Management Devices. White Paper. Data on file,
ConvaTec.
(2) U.S. Department of Health and Human Services, Centers for Medicare &
Medicaid Services. 42 CFR Parts 411, 412, 413, and 489. Medicare Program;
Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year
2008 Rates. Federal Register. 2007;72(162):47130,47200.
(3) Wishin J, Gallagher TJ, McCann E. Emerging options for the management of
fecal incontinence in hospitalized patients. J Wound Ostomy Continence Nurs.
2008;35(1):104-110.
(4) Pressure ulcers in America: prevalence, incidence and implications for the
future. An executive summary of the National Pressure Ulcer Advisory Panel
monograph. Advances in Skin and Wound Care. 2001; 14:208-215.
(5) 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.
(6) HPIS. Moving Annual Total (MAT) Fecal Control Category. Q1 2008 data. Data
on file, ConvaTec.
(7) Cognos. Redistributed YTD Sales through May 2008.  Data on file, ConvaTec.
(8) Inventiv. Monthly In-Service Report through June 2008. Data on file,
ConvaTec.


    Contacts:
    Punnie Donohue
    Weber Shandwick
    212-445-8163
    PDonohue@webershandwick.com

    Nimisha Savani
    ConvaTec
    908-904-2522
    Nimisha.Savani@convatec.com





SOURCE  ConvaTec Inc.

Punnie Donohue of Weber Shandwick for ConvaTec, +1-212-445-8163,
PDonohue@webershandwick.com; or Nimisha Savani of ConvaTec, +1-908-904-2522,
Nimisha.Savani@convatec.com
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