ConvaTec Extends Leadership Position in Fecal Management Systems with Launch of Flexi-Seal® CONTROL™ FMS


First and Only Fecal Management System to Automatically Protect Against Over-inflation of Device's Retention Balloon

Skillman, New Jersey (March 5, 2013)- ConvaTec, a world-leading developer and marketer of innovative medical technologies, today announced the U.S. launch of Flexi-Seal® CONTROL™ FMS, extending the company's leadership position in fecal management systems. Flexi-Seal® FMS is used by more hospitals and nurses than any other fecal management system in the world.

Flexi-Seal® CONTROL™ FMS, an advanced containment device for patients with acute fecal incontinence, is the first and only fecal management system that automatically protects against over-inflation of the device's retention balloon, ensuring an optimal fit and maximum effectiveness.

Fecal incontinence, a common condition affecting patients in intensive care, places a heavy burden on hospitals and carries significant risks to patients. Complications and harmful effects include skin breakdown and the development of pressure ulcers, as well as the spread of C.difficile, a dangerous bacterium, from infectious diarrhea.

"ConvaTec developed Flexi-Seal® CONTROL™ FMS to provide the most advanced health, economic and environmental benefits for hospitals and patients," said Mark Valentine, President, Americas. "The new system is designed to provide the same skin protection and infection containment benefits as existing Flexi-Seal® systems, plus new features that improve patient care and - priced at parity with Flexi-Seal® SIGNAL™ FMS - deliver more value."

The new features of Flexi-Seal® CONTROL™ FMS include a unique control valve that automatically shuts off once the optimal fill volume of the device's retention balloon is reached. This ensures optimal usage of the device and a secure, individual fit to protect the patient's skin from harmful effluent.

In addition to automatic fill control, Flexi-Seal® CONTROL™ FMS introduces total odor control combined with infection control, contributing to a better and safer environment for patients, visitors and hospital staff. Unique, end-to-end odor protection is provided by an advanced odor barrier that runs the full length of the tubing and a bag filter that has six times more odor-absorbing capacity, as demonstrated in vitro. The new Privacy™ Bag also allows clinicians to monitor waste collection without compromising patient privacy.

Flexi-Seal® CONTROL™ FMS has been proven, in vitro, to contain the spread of C.difficile infection. In addition, the closed system may help to reduce additional environmental contamination from other deadly pathogens, such as extended-spectrum beta-lactamase (ESBL) producing bacteria and methicillin-resistant Staphylococcus aureaus (MRSA).

About Flexi-Seal® Fecal Management from ConvaTec

Flexi-Seal® FMS is a temporary containment device that has been shown to safely and effectively divert fecal matter, helping protect patients' skin from breakdown. It is the only fecal management system that has been proven, in vitro, to contain the spread of C.difficile infection. Flexi-Seal® FMS is indicated for patients with little to no bowel control and liquid or semi-liquid stool, and can be used for up to 29 consecutive days.

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