Better Urinary Catheterization Outcomes Hinge on Innovation.

Growing recognition within the medical community of the limitations of existing urinary catheters is fueling interest in new approaches to device design. Despite being one of medicine's most widely used tools, the urinary catheter has seen little fundamental innovation since Dr. Frederic Foley introduced his eponymous catheter in the 1930s.

The issue was highlighted last month at the American Urological Association's annual meeting in Washington, DC, where Dr. Sara Lenherr addressed emerging trends in urinary catheter development during her State-of-the-Art Lecture.

As opposed to “just living with the same catheter design that we’ve had for a long time,” Dr. Lenherr exhorted her fellow urologists to utilize their expertise to improve upon it.

“We have the understanding and the knowledge about bladder physiology to help inform the creative choices that we could make to make our patients’ lives better. The urinary catheter design really has consequences on the patient on their day-to-day experience.”

Among the areas of innovation discussed by Dr. Lenherr were mechanical, drainage, materials science, and safety. Notably, many of these approaches rely on the assumption that a catheter has been successfully advanced into the bladder in the first place. (As Dr. Lenherr limited her talk to only catheters that have obtained FDA 510(k) clearance, Foldé was not mentioned.)

Foldé’s own approach has been to focus on increasing first-attempt insertion success by engineering a catheter that will more flexibly conform to any given patient’s unique anatomy, however tortuous or narrow. Their hope is to reduce the incidence of difficult or traumatic urinary catheterizations, from which hundreds of thousands of patients in the US suffer on an annual basis. Foldé will be submitting its FDA STeP application imminently.