image: The RELIEF Ureteral Stent, Invented by UH Urologist Dr. Lee Ponsky, Secures FDA Clearance as First and Only Stent for Prevention of Vesicoureteral Reflux.
Credit: Ureteral Stent Company
The RELIEF™ ureteral stent has achieved FDA clearance as the first and only stent to have approval for the prevention of vesicoureteral reflux, a major cause of patient discomfort. RELIEF’s unique suture design allows natural opening and closing of the ureteral orifice, thereby preventing vesicoureteral reflux.
In 2022, the RELIEF stent achieved a major milestone by securing its FDA 510k clearance, meaning it could be marketed in the U.S. for patients suffering from kidney stones and other issues causing difficulty with drainage of the kidney. This latest FDA clearance now means the RELIEF stent can be marketed in the U.S. for preventing reflux.
Ureteral stents allow urine to flow from the kidney to the bladder, bypassing blockage caused by kidney stones, strictures or swelling of the ureter (which connects the kidney to the bladder). 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 0% 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.
The RELIEF stent was invented by Lee Ponsky, MD, FACS, 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,” said Dr. Ponsky. “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.” Dr. Ponsky is also the Leo & Charlotte Goldberg Chair in Advanced Surgical Therapies and Master Clinician in Urologic Oncology at UH.
David Schulsinger, MD, Director of Endourology and Stone disease at Stony Brook Medicine in Long Island, NY, and Chair of the company’s Scientific Advisory Board said, “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.”
The Ureteral Stent Company, which developed the RELIEF stent, is currently starting a limited market introduction to further clinical experience with its novel stent. If you have interest or would like more information about the RELIEF stent, please contact info@waldencompanies.com.
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About University Hospitals / Cleveland, Ohio
Founded in 1866, University Hospitals serves the needs of patients through an integrated network of more than 20 hospitals (including five joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University, Taiwan National University College of Medicine and the Technion Israel Institute of Technology. The main campus also includes the UH Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees. Follow UH on LinkedIn, Facebook and Twitter. For more information, visit UHhospitals.org.
About The Ureteral Stent Company / Cleveland, Ohio
The Ureteral Stent Company has developed a novel ureteral stent, the RELIEF Stent™, to improve the common urological challenge for bypassing kidney stones, strictures or swelling of the ureter. The RELIEF stent has the only FDA clearance for patients suffering from reflux associated with stent placement, which occurs 63% of the time with standard Double J stents. The RELIEF stent has a 4 cm tether of suture material that is placed along the ureter intramural segment, allowing natural opening and closing of the ureteral orifice, thereby preventing vesicoureteral reflux. If you have interest in evaluating the RELIEF stent in the Limited Market Release, please contact us at info@waldencompanies.com or visit RELIEFstent.com.