hygh-tec Study Results Demonstrate High Performance and Safety

Fecal incontinence is a significant and insufficiently resolved clinical problem in intensive care, as it increases the risk of complications, impacts patient well-being, and places a heavy burden on staff and resources. The stool drainage systems currently used by hospitals are associated with leakage in up to 30% of ICU patients, low anal/rectal tolerance, and safety concerns. Severe skin breakdowns and ulceration can lead to a potentially life-threatening infection (e.g., Clostridioides difficile), increased sepsis risk, and reduced patient mobility. The labor-intensive process of frequently cleaning patient beds is inefficient and places a heavy burden on nursing staff, contributing to increased burnout and staff resignations.

To address the challenges associated with fecal incontinence, Advanced Medical Balloons GmbH (AMB) has developed a new polyurethane (PU) stool drainage system, hygh-tec, based on the use of thin PU films. The company conducted an observational study (HYDRA-PMCF) to assess hygh-tec’s sealing efficiency and product safety. The study included 39 ICU patients aged 18 and older. Study organizers evaluated the sealing efficiency based on nursing shift documentation using a predefined contamination score (rank 1 to 4). The safety endpoints focused on the prevalence of perianal lesions and the perianal skin status, as measured by the GLOBIAD score (Ghent Global Incontinence-Associated Dermatitis Categorisation Tool).

HYDRA-PMCF evaluated sealing performance across 1,110 nursing shifts, with no drainage-associated SAEs reported. The mean duration of the drainage was 10.8 days (median: eight days, minimum: three days, maximum: 31 days). Stool consistency, depth of sedation and level of mobilization were recorded once a day. No visible perianal contamination (rank 1) was found in 76% of subjects, visible perianal contamination (rank 2) was observed in 13.2% of participants, while a visible contamination of patient pad (rank 3; 7.57%) and marked patient contamination (rank 4; 3.15%) occurred less frequently. Leakage was defined as a scale of 3 or 4; accordingly, 10.7% of patients experienced leakage (119 shifts), no leakage was experienced in 89.3% (991 shifts) of patients. The perianal skin status showed that in 362 of 384 days (94.2%), no signs of infection were observed (GLOBIAD score 0=78.6%; 1A=15.6%). None of the clinical events reported were related to the device.

Data from the HYDRA-PMCF-study have already been discussed at the Boswick Burn & Wound Care Symposium in January and at the North American Burn Society (NABS) Meeting in February. The full results will be presented later this week at the ABA Annual Meeting (April 10) in Phoenix, and at the WOCNext 2025 on June 1 in Orlando, Fla.

Related: Advanced Medical Balloons Expands its Catheter Product Lineup

“We are very pleased with the results of the HYDRA-PMCF study, which clearly demonstrate the effectiveness and safety of hygh-tec,” Advanced Medical Balloons Chief Medical Officer Prof. Andreas Pfuetzner, M.D., Ph.D., said. “Eliminating one of the key hygiene challenges in the ICU—fecal contamination in the bed—not only reduces nursing workload but also helps prevent costly medical complications such as lesions, infection spread, and delayed mobilization. Given these benefits, hygh-tec is set to become an indispensable tool for burn patients, those at risk of skin ulceration, and patients requiring early mobilization for better care and faster healing.”

AMB’s flagship product hygh-tec is designed for urgent care in hospitals, including intensive care units, burn units, and other specialized departments, where managing fecal output is critical. hygh-tec, which is CE-marked and received U.S. Food and Drug Administration approval in 2023 as well as MDR approval in 2024, is a novel fecal management system that provides a safe and effective solution for managing fecal incontinence, reducing the risk of skin breakdown and pressure injuries. The technology represents a paradigm shift in fecal management and the critical need to reduce leakage in these critical care departments. In addition, AMB has developed a pipeline of products addressing unmet clinical needs, including significantly improved endotracheal tubes for mechanical ventilation and novel urinary catheters, addressing a market potential worth more than $2 billion annually.

Advanced Medical Balloons (AMB) is a specialized medical technology company developing and marketing catheter technology based on microscopically thin, complex shaped balloon films made of polyurethane (PUR). AMB taps the properties of these structures for problem-solving platform concepts in the fecal, urinary and respiratory segments. The current focus is on systems for the containment of patient contamination. In this context, AMB is developing contamination-free drainage technology for fecal management in intensive care patients, which provides significant benefits in nursing, hygiene management, and patient therapy. AMB was founded in 2009 and is based in Waghäusel, near Heidelberg, Germany, and in Atlanta, Ga. Since 2021, the company has been financed by a strong investor syndicate led by Wellington Partners, Munich, and comprising MIG AG as well as Salvia GmbH.