Innovative System Maintains Skin Condition, Supple and Flexible Design
Helps Reduce the Risk of Pressure Ulcers
ST-LAURENT, QC, June 6 /CNW/ - ConvaTec, a world-leading manufacturer of
ostomy and wound care products, today announced that its Flexi-Seal(R) Fecal
Management System (FMS), a temporary containment device indicated for
immobilized, incontinent patients with liquid or semi-liquid stool, has been
redesigned for easier use and storage.
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
Clostridium difficile (C. difficile).(1) The improved Flexi-Seal(R) FMS
retains all of the original product benefits, but also now includes recyclable
and re-closeable molded plastic packaging that is 25 percent smaller than the
original package size and allows for easy storage of collection bags and
syringes; a new blue irrigation port that allows for immediate identification;
a re-labeled syringe that is precisely marked to 45 ml and measures the exact
amount of water or saline necessary; and a smaller, more user-friendly,
pocket-size package insert. The new and improved Flexi-Seal(R) FMS will be
available to medical professionals in Canada starting from fall 2008, at no
increase in cost.
"The upgrades to the Flexi-Seal(R) Fecal Management System were based
upon the feedback we received from our customers - critical care nurses who
use Flexi-Seal(R) FMS on a regular basis and provide exceptional care to the
patients who benefit from the system," said Nino Pionati, Senior Vice
President of Global Marketing and Business Development at ConvaTec. "Interest
in Flexi-Seal(R) FMS has continued to expand since its introduction,
particularly in light of the increased focus on pressure ulcer prevention and
the ongoing focus on infection control in general."
About Flexi-Seal(R) Fecal Management System
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 closed-end collection bag which may help reduce the spread of
- A soft, low-pressure balloon designed to minimize the chance of
- A soft, flexible silicone catheter that can collapse to an 8 mm
diameter after insertion and conform to sphincter tone and anatomy.
- An entirely latex-free design.
A prospective, phase II, open-label, non-randomized clinical study
involving 42 patients from seven U.S. hospitals was performed to evaluate the
safety of Flexi-Seal(R) FMS.(1) The study found that Flexi-Seal(R) FMS
maintained or improved skin condition in 92 percent of patients, and that use
of the device revealed no adverse effect on rectal mucosa. Most patients were
able to retain the device until removal. Caregivers from both the intensive
care units and acute care units reported that Flexi-Seal(R) FMS improved
control of fecal incontinence with minimal leakage, and was practical,
efficacious, time-efficient, and both caregiver and patient-friendly. Four
subjects experienced non-serious adverse events. One subject, who had a
history of gastrointestinal (GI) bleeding, developed a lower GI bleed with
ulceration four days after placement of the device, and was discontinued from
the study. The event was considered to be related to the use of the device.
Five subjects expired during the study, and all deaths were determined to be
unrelated to the device.
ConvaTec, a world-leading manufacturer of ostomy and wound care products,
is at the forefront of the movement to change the way health care
professionals are managing chronic and acute wounds. Since the introduction of
DuoDERM(R) Hydroactive Dressing in 1982, ConvaTec has been a pioneer in the
establishment of moist wound healing. Today, ConvaTec is building on this
strong heritage with its Hydrofiber(R) technology, featured in advanced wound
dressings such as AQUACEL(R) Ag, an absorbent, soft, conformable,
antimicrobial dressing with ionic silver, which forms a cool gelling sheet on
contact with exudate. ConvaTec is a Bristol-Myers Squibb Company (NYSE: BMY), a
global pharmaceutical and related health care products company. For more
information, please call 800-465-6302 or visit www.convatec.com.
Flexi-Seal, DuoDERM, Hydrofiber and AQUACEL are registered trademarks of
E.R. Squibb & Sons, L.L.C.
(C) 2008 E.R. Squibb & Sons, L.L.C.
(1) Padmanabhan A., Stern M., Wishin J., Mangino M., Richey K.,
DeSane M. Clinical evaluation of a flexible fecal incontinence
management system. American Journal of Critical Care, July 2007;
Volume 16, No. 4.
For further information:
For further information: Punnie Donohue, Weber Shandwick, Phone: (201)
704-2263, PDonohue@webershandwick.com; Nimisha Savani, ConvaTec, Phone: (908)
904-2522, Nimisha.Savani@bms.com; Pete Paradossi, Bristol-Myers Squibb, Phone:
(812) 429-7413, Pete.Paradossi@bms.com