FDA grants 510(k) clearance to RELIEF stent for vesicoureteral reflux

The FDA has granted 510(k) clearance to the RELIEF ureteral stent for the prevention of vesicoureteral reflux, University Hospitals in Cleveland, Ohio announced in a news release.¹

The RELIEF stent was previously granted FDA clearance in 2022.

This clearance marks the first approval of a stent for this indication in the US. The RELIEF stent was previously granted FDA clearance in 2022 for the management of kidney stones and other issues causing difficulty with drainage of the kidney.

With its clearance for vesicoureteral reflux, the Ureteral Stent Company, the developers of the stent, have initiated a limited market introduction to gain additional clinical experience with the device. The current standard for the management of vesicoureteral reflux are Double J ureteral stents.

“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,” said Lee Ponsky, MD, FACS, who developed the RELIEF stent alongside Dean Secrest.¹ “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 very 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.”

Data on the RELIEF Stent

The efficacy and tolerability of the RELIEF stent were demonstrated in a single-institution study published in Urology.² In total, the study included 28 patients, of whom 20 underwent RELIEF stent placement. Of those, 11 patients were female and 9 were male.

For the study, patients received passive cystography before and after stent placement. Patients also completed the Ureteric Stent Symptoms Questionnaires (USSQ) at baseline, post-op day 1, and on the day of removal.

Overall, 95% of patients (18 of 19) showed no radiographic urinary reflux on cystography following stent placement. One patient experienced grade 1 reflux. Two patients were excluded intraoperatively due to concern for ureteral trauma, and 1 patient chose to have their stent removed early due to significant discomfort.

No patients experienced adverse complications.

Additionally, results showed a statistically significant improvement in the first and third average total USSQ survey scores (P < .001). Statistically significant improvements were also noted in body pain, general health, and work performance scores (P < .05).

According to the authors, USSQ scores with the RELIEF stent were significantly below the published mean symptom scores for standard Double J stents. Among those who receive Double J ureteral stents, 63% experience pain related to vesicoureteral reflux, University Hospitals noted in the news release.

Further, on cytometric evaluation with 150cc and 300cc contrast, 76% and 71% of patients, respectively, showed the distal coil resting on the trigone. At the time of removal of the stent, this was improved by 23% and 18%, respectively.

Overall, the authors concluded, “Based on this preliminary clinical trial, the RELIEF stent design appears safe, reliable, and easy to adopt by current-day urologists, highlighting its potential for widespread use.”

References

1. The RELIEF ureteral stent, invented by UH urologist Dr. Lee Ponsky, secures FDA clearance as first and only stent for prevention of vesicoureteral reflux. News release. University Hospitals Cleveland Medical Center. December 20, 2024. Accessed January 14, 2025. https://news.uhhospitals.org/news-releases/articles/2024/12/relief-ureteral-stent-secures-fda-clearance

2. Callegari M, Patel A, Drozd A, et al. Novel antireflux “RELIEF” Stent to prevent vesicoureteral reflux. Urology. 2024;187:100-105. doi:10.1016/j.urology.2024.02.032