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, as announced by University Hospitals in Cleveland, Ohio. This clearance is notable as it represents the first approval of a stent for this indication in the United States. Previously, in 2022, the RELIEF stent received FDA clearance for managing kidney stones and other conditions that hinder kidney drainage.

The RELIEF stent's development was motivated by the need to overcome the limitations of existing Double J ureteral stents, which are currently the standard for managing vesicoureteral reflux. Dr. Lee Ponsky, MD, FACS, who co-developed the RELIEF stent, highlighted the discomfort patients often experience with current stents. The RELIEF stent's design, featuring a floating coil in the bladder, aims to minimize bladder spasms and prevent painful reflux into the kidney during voiding.

A single-institution study published in Urology demonstrated the RELIEF stent's efficacy and tolerability. The study involved 28 patients, with 20 undergoing RELIEF stent placement. Results showed that 95% of patients exhibited no radiographic urinary reflux post-stent placement, with significant improvements in patient-reported outcomes, including body pain, general health, and work performance. The study concluded that the RELIEF stent design is safe, reliable, and easy for urologists to adopt, suggesting its potential for widespread use.

The RELIEF stent's approval and the positive outcomes from the study represent a significant advancement in the treatment of vesicoureteral reflux, offering patients a less painful and more effective option compared to existing stents.