Advanced Balloon Catheter System Enables Contamination-Free Stool Drainage for ICU Patients

A new fecal management system has now been developed to provide reliable, contamination-free stool drainage, ensuring maximum sealing and prevention of fecal leakage in intensive care patients.

Advanced Medical Balloons (Waghaeusel, Germany) has introduced the FDA-cleared hygh-tec, an innovative catheter system for stool drainage in ICU settings, to the U.S. market. The hygh-tec system features a unique elastic and deformable polyurethane catheter tube, offering unparalleled trans-anal sealing performance. It adheres to the rectal mucosa without tension and naturally adjusts to the patient's sphincter dynamics and movements. This intelligent synchronization with the sphincter enables the device to adapt to changing pressures. As the sphincter muscle's tone decreases and opens, the sheath can spontaneously straighten in the anal canal, allowing for unobstructed defecation.

“We are delighted that the FDA cleared hygh-tec, which is a major milestone for AMB in accessing the U.S. market. Offering the first product from our unique portfolio in the U.S. for medical supply of ICU patients makes us very proud,” said Frank Gehres, CEO of Advanced Medical Balloons. “hygh-tec’s reliably high leak tightness means a significant reduction in workload and saving time for caregivers. The trans-anal sealing mechanism could also support early mobilization of cardiac patients or contribute to preventing infection in severely burnt patients. For physicians, this smart fecal management opens up novel therapeutic possibilities.”