October 23, 2008
ConvaTec Introduces Flexi-Seal(R) FMS Advanced Odor Control
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 Clostridium difficile (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).
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 http://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 [email protected] Nimisha Savani ConvaTec 908-904-2522 [email protected]
Web Site: http://www.convatec.com/