ConvaTec releases new fecal management system in US

Global medical technology company ConvaTec Group announced the US launch of the Flexi-Seal PROTECT Fecal Management System on Tuesday, following receipt of 510(k) clearance from the US Food and Drug Administration.

The FTSE 100 firm said Flexi-Seal PROTECT FMS was the latest addition to the company's “market-leading range” of advanced systems developed to manage acute fecal incontinence, and help to reduce the associated risks of skin breakdown and spread of C. difficile infection.

It said the new product was designed to provide protection for both patients and clinicians in a “number of innovative ways”.

That included fill protection, with the board claiming it was the only system that sensed when the retention balloon is correctly filled and visually indicated over-inflation, and patient protection, with the blue finger pocket allowing easy and accurate placement of the soft silicone retention balloon.

It also offered privacy and odour protection, with the privacy bag letting clinicians monitor volume without compromising patient privacy; and the odour barrier running the full length of the catheter providing an end-to-end odour barrier.

“Acute fecal incontinence is a significant issue for hospitals and presents numerous management challenges for clinicians and patients, including an increased risk of pressure injury - pressure ulcer - development as well as the risk of infection spread associated with C. difficile-related diarrhea,” the ConvaTec board said in a statement.

“ConvaTec developed Flexi-Seal PROTECT FMS to help clinicians address these many challenges.

“A temporary containment device indicated for incontinent patients with liquid or semi-liquid stool, Flexi-Seal PROTECT FMS is designed to effectively contain and divert fecal matter, and has been proven, in vitro, to contain C. difficile and its spread into the environment.”

The U.S. launch of Flexi-Seal PROTECT FMS followed the launch of ConvaTec's Sensi-Care Skin Protectant Incontinence Wipes last month, adding to the company's range of products to help healthcare professionals protect a patient’s skin and lessen associated risks such as pressure injury development and infection.

“Flexi-Seal PROTECT FMS demonstrates our continuing commitment to innovation in critical care, responding to and addressing the needs of customers and patients," said Mads Haugaard, vice president and general manager of continence and critical care at ConvaTec.

“Our goal is to help protect these critically ill patients by minimizing the risks of complications such as skin breakdown and infection spread as well as to help ensure its safe and effective use by the critical care team.”

Following the US launch, ConvaTec said Flexi-Seal PROTECT FMS would be rolled out in additional markets throughout 2017.