FDA Clears Hygh-Tec Catheter System for ICU Stool Drainage

Advanced Medical Balloons GmbH (formerly Creative Balloons GmbH) is expanding its intensive care business to the United States following U.S. Food and Drug Administration (FDA) approval of its catheter system hygh-tec.^1,2 The fecal management system hygh-tec provides maximum seal and prevents fecal leakage in patients receiving intensive care.
 
“We are delighted the FDA cleared hygh-tec, which is a major milestone for AMB in accessing the U.S. market. Offering the first product from our portfolio in the U.S. for medical supply of ICU patients makes us very proud,” Advanced Medical Balloons CEO Frank Gehres said. “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.”
 
Along with the start of U.S. sales, the company has operated globally as Advanced Medical Balloons (AMB) since April 1. Based in Atlanta, Ga., AMB is currently establishing its own U.S. sales structure under the leadership of General Manager Kent Johnson. “While building out our commercial team, we have initiated clinical use in ICU patients in the U.S. and are rolling out hygh-tec with intensive care clinicians throughout the country,” he stated. “We have already seen very encouraging feedback from healthcare professionals confirming their need for a next-generation fecal management system, and I am extremely positive regarding our commercial success.”

“While hygh-tec is already established in its lead market Germany, where we currently have almost a quarter of market share in ICUs and are continuously growing, the U.S. is the most important market for AMB, globally. With approximately 110,000 intensive care beds, we see a market potential in the mid three-digit million range,” Gehres noted. “I am therefore very pleased that we have been able to win Dr. Ramona Koenig as chief operating officer to support the roll-out of our products and the expansion of our business activities.”

Koenig, a trained physicist with a Ph,D, in physical chemistry, joined AMB this past spring from Rottendorf Pharma.

The technical basis for hygh-tec is its design of the elastic and deformable polyurethane catheter tube, which allows an unmatched trans-anal sealing performance. It clings to the rectal mucosa free from tension and spontaneously adapts to the sphincter dynamics and movements of the patient. By adapting to the current pressure, intelligent synchronization with the sphincter is possible. When the tone decreases and the sphincter muscle opens, the sheath can spontaneously straighten in the anal canal and allows unobstructed defecation.

Advanced Medical Balloons develops and markets catheter technology based on microscopically thin, complex shaped balloon films made of polyurethane (PUR). AMB taps the properties of these extraordinary 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. The first product utilizing this technology, hygh-tec, is already used in German-speaking countries with great success. AMB was founded in 2009 by Dr. med. Fred Göbel and is based in Waghäusel, near Heidelberg, Germany, and in Atlanta, Ga. 

References 
¹ From the letter of authorization: “The hygh-tec drainage is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liquid stools and to provide access for the administration of medications. The device is not intended for use on pediatric patients.” U.S. Food and Drug Administration, 2023
²  hygh-tec® is a registered trademark of Advanced Medical Balloons GmbH.