Navigation Links
ConvaTec Introduces Enhanced Flexi-Seal® SIGNAL® FMS
Date:6/12/2012

SKILLMAN, N.J., June 12, 2012 /PRNewswire/ -- ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, announced today the launch of enhanced Flexi-Seal® SIGNAL® Fecal Management System (FMS). 

Already available in Canada and now in the U.S., Flexi-Seal® SIGNAL® FMS has been enhanced with nurse-inspired features to respond to clinicians' needs.

In addition to the original innovative design and SIGNAL™ indicator, Flexi-Seal® SIGNAL® FMS enhancements include:

  • A sampling port designed for safe and easy stool collection and to help decrease risk of exposure to infectious stool
  • A simple medication delivery process to allow prescribed medication rectally via the irrigation port, without complicating the use of the device
  • An extended catheter that adapts to a range of bed sizes and accommodates a variety of patient heights and weights

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

Flexi-Seal® FMS is used by more nurses and hospitals than any other fecal management system in the world.(1)

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. This 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. 

Other key features of Flexi-Seal® SIGNAL® FMS include:

  • 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.*
  • A soft, low-pressure balloon designed to aid easy insertion and removal and minimize the chance of tissue necrosis.
  • A closed-end 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 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.
  • A versatile strap designed to securely lock onto an open bed frame, also helping to minimize the risk of contamination that might result from spillage. 
  • Does not contain natural rubber latex components.

Clinical Evidence

Flexi-Seal® SIGNAL® FMS has been scientifically proven in vitro to contain the spread of C. difficile.(2)

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:(3)

  • 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.

* Signal indicator could pop before 45mL if the space available for the balloon is smaller than the balloon. Filling should stop when the indicator pops out and stays out. More than 45mL is never to be added to the balloon.

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 focus areas – Ostomy Care, Wound Therapeutics, Continence and Critical Care, and Infusion Devices – ConvaTec products support healthcare professionals from the hospital to the community health setting. For more information, please visit www.convatec.com.

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

(2) Jones S, Towers V, Welsby S, Wishin J, Bowler P. Clostridium difficile Containment Properties of a Fecal Management System: An In Vitro Investigation. Ostomy Wound Management, 2011;57(10):38-49.

(3) 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.

®/™ indicates trademarks of ConvaTec Inc.

© 2012 ConvaTec Inc.                                                                                         


'/>"/>
SOURCE ConvaTec
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. ConvaTec Announces Acquisition of AbViser Medical, LLC
2. ConvaTec Donates $10,000 To AAWC Global Volunteers Program Through SAWC Walk For Wellness
3. IDEV Technologies Introduces SurePath™ Guidewires
4. Velos, Inc. Introduces Mobile App for Oncology Adverse Events and Graft-Versus-Host Disease at 2012 ASCO Annual Meeting
5. Rochester Medical Introduces Magic3® Coude Tip Hydrophilic Intermittent Catheter
6. Richard Wolf Medical Instruments introduces groundbreaking 5514 Endocam Performance HD
7. Pernix Therapeutics Introduces Omeclamox-Pak®, First Product in Gastroenterology Portfolio
8. IRIDEX Introduces Non-Invasive MicroPulse™ Therapy for Glaucoma
9. Polaris Group Lead Therapeutic Candidate ADI-PEG 20 Demonstrates Potential Anticancer Activity in Various Metastatic Sarcomas and Bladder Cancers That Are Deficient in Key Metabolic Protein, and Enhanced Effects with Combination Therapy in Melanoma
10. PharMEDium Highlights Enhanced Labeling for ICU Services at Critical Care Expo
11. Ceregene Parkinsons Disease Study Demonstrates Long-term Neurturin Expression and Enhanced Dopamine Activity 4 Years Following Delivery of CERE-120 (AAV2-neurturin)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... OLD LYME, Conn. , Dec. 1, 2016 /PRNewswire/ ... consulting, has announced the honor of being selected as ... that include: Simpson Healthcare Executives Website at the PLATINUM ... Directed Conversations Training Module at the GOLD Level, and ... At Simpson Healthcare Executives, we are ...
(Date:12/2/2016)... , Dec. 2, 2016 Allergan plc (NYSE: ... additional information on its previously announced Accelerated Share Repurchase (ASR) ... ... As previously announced, the Company entered into ... which the Company will repurchase $10 billion of its ordinary ...
(Date:11/30/2016)... -- Research and Markets has announced the addition of ... report to their offering. ... Detachable coil embolization is a minimally ... detachable coil embolization treatment of cerebral aneurysms is less invasive and requires ... in the wall of an artery in the brain. This area bulges ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... , ... For over twenty-four years, Doctors on Liens has published a directory of ... quality medical care. When the company started in 1997, the directory was a single ... and the now ten-page directory features a vast array of medical specialists stretching ...
(Date:12/2/2016)... Portland, Maine (PRWEB) , ... December 02, 2016 , ... ... support group for caregivers of those affected by autism spectrum disorder (ASD) and other ... and Easter Seals Maine, will give parents and other caregivers the opportunity to share ...
(Date:12/2/2016)... New York, NY (PRWEB) , ... December 02, ... ... today, featuring an inspirational interview of two ostomy patients, standing as living proof ... million people suffer from digestive diseases and issues that spike around the holidays. ...
(Date:12/2/2016)... Wilmington, Delaware (PRWEB) , ... December 02, 2016 ... ... has released a new version of its SaaS LIMS, CloudLIMS Lite. CloudLIMS Lite ... from sample entry through labeling, storing, shipping and disposal. The new version is ...
(Date:12/2/2016)... PA (PRWEB) , ... December 02, 2016 , ... Rijuven ... stress and overall health, day and night. No other wearable health technology on the ... We wanted to give poeple more meaningful insights about their health than the ...
Breaking Medicine News(10 mins):