The U.S. Food and Drug Administration (FDA) has cleared the Ureteral Stent Company’s RELIEF ureteral stent to prevent vesicoureteral reflux, a major cause of patient discomfort. RELIEF’s suture design allows natural opening and closing of the ureteral orifice, thereby preventing vesicoureteral reflux.

The RELIEF stent is already FDA-cleared (2022) to treat U.S. patients suffering from kidney stones and other kidney drainage issues. This latest authorization now allows the RELIEF stent to be marketed in the United States as a reflux prevention solution.

“The RELIEF stent has potential to improve patient comfort, decrease medication use and become the standard of care in kidney stone management. I am proud to be involved with this product and the significant benefit this stent offers patients,” said David Schulsinger, M.D., director of Endourology and Stone disease at Stony Brook Medicine (Long Island, N.Y.) and Ureteral Stent Company Scientific Advisory Board chair.

Ureteral stents allow urine to flow from the kidney to the bladder, bypassing blockages caused by kidney stones, strictures, or ureter swelling. Currently available ureteral stents can have complication rates as high as 80%, causing significant patient pain and discomfort from urine reflux, flank pain, and bladder spasms, often leading to additional medical attention and replacement procedures. Urine reflux is well-documented as a leading cause of pain and discomfort in patients and can lead to kidney damage or infections, which may require hospitalization.

Pain related to vesicoureteral reflux occurs 63% of the time with the current standard, Double J ureteral stents. In contrast, a clinical study using the RELIEF stent demonstrated no vesicoureteral reflux, documented by visual evidence of cystogram pictures showing reflux did not occur when the RELIEF stent was in place, leading to the FDA labeling claims. This is a promising new alternative to currently available ureteral stents, according to Ureteral Stent Company.

The RELIEF stent was invented by Lee Ponsky, M.D., chairman of the University Hospitals Urology Institute, in collaboration with Dean Secrest, due to his own experience with kidney stones.

“I understood the problems with existing Double J stent designs from not only my clinical work in urology, but also from the experience I had myself as a ureteral stent patient,” explained Dr. Ponsky, the Leo & Charlotte Goldberg Chair in Advanced Surgical Therapies and Master Clinician in Urologic Oncology at UH. “Using current stents is often painful for patients. The RELIEF Stent addresses the most significant side effects, such as reflux and bladder spasms, in a way that is quite intuitive. The coil in the bladder is different than standard stents as it floats, and therefore doesn’t sit on the floor of the bladder. This floating coil is designed to minimize bladder spasms which is a common symptom from standard stents. The unique design allows the opening from the ureter into the bladder to remain closed during voiding, so that there is no painful reflux up into the kidney. We are excited for patients to have an option that really differentiates itself from all other existing stents, and we look forward to seeing patients’ improved quality of life through this novel design.”

The Ureteral Stent Company, which developed the RELIEF stent, is currently starting a limited market introduction to further the stent’s clinical experience.