FDA clears Novel stent for facilitating drainage in kidney stone patients

A new urinary stent invented by Lee Ponsky, MD, Chair of the Department of Urology and the Leo & Charlotte Goldberg Chair in Advanced Surgical Therapies at University Hospitals (UH) in Cleveland, in collaboration with Dean Secrest, recently achieved a major milestone by securing its FDA 510k clearance. This FDA clearance now means the Relief™ Stent can be marketed in the United States for patients suffering from kidney stones and other issues causing difficulty with drainage of the kidney.

Ureteral stents ease urine flow from the kidney to the bladder to prevent kidney damage caused by kidney stones, strictures or swelling of the ureter (which connects the kidney to the bladder).

Existing ureteral stents currently on the market have complication rates as high as 60 percent, causing significant patient pain and discomfort, including urine reflux, flank pain and bladder spasms, and leading to additional medical attention and replacement procedures. Urine reflux is well documented as a leading cause of pain and discomfort and can lead to kidney damage and kidney infections, which may require hospitalization.

However, because of its unique suture design, allowing the ureteral orifice to close naturally and reduce reflex of urine back into the kidney, the Relief Stent offers the potential to reduce significantly these side effects and provides more effective management of patients suffering from kidney stones and other similar disorders.

"I developed the Relief Stent from not only my work as a physician, but also from the experience I had myself as a ureteral stent patient," said Dr. Ponsky, who is a urological surgeon, "Using current stents is often painful for patients. The Relief Stent addresses the most significant side effects, reflux and bladder spasms, in a way that is quite intuitive, allowing the opening from the ureter into the bladder to remain closed during voiding and avoiding painful reflux up into the kidney.

More than 3 million ureteral stent placements occur annually worldwide.

The successful journey of Relief Stent from concept, research, development, and commercialization has its origins in Cleveland. Dr. Ponsky was able to take his idea, which was conceived in the operating rooms of UH, to a commercial-ready implantable device with the help of UH Ventures and area investors. Subsequently, the Relief Stent has demonstrated early success in preclinical study cases being performed at UH.

UH Ventures, the UH system's commercialization arm, invested in the company and helped Dr. Ponsky obtain funding from the State of Ohio's Technology Validation and Start Fund (TVSF) of the Ohio Third Frontier. TVSF's aims to accelerate and fund the translation of promising technologies through Ohio start-up companies with the eventual goal of creating greater economic growth.

Furthermore, ProMedica Innovations invested in Ureteral Stent Company, founded by Dr. Ponsky as a subsidiary of Walden Medical Companies, based in Cleveland, to bring this device to fruition.

UH Ventures Vice President Neil Wyant, said, "UH licensed the technology to The Ureteral Stent Company, and the UH Ventures team has had the privilege to work closely with Dr. Ponsky and the Company as it has developed the product and achieved this critical milestone. It's a great example of how to efficiently move medical devices from ideation to commercialization."

Kyle Scarberry, MD, a urologist at UH who is the principal investigator of the Relief stent study, said, "This is a significant milestone for the Relief Stent which has potential to improve patient comfort and quality of life, while it also aims to improve hospital economics by reducing readmissions and replacement costs that will be part of post-market studies with this FDA clearance. This should also accelerate clinical introduction of the stent and further collaboration with the company's existing clinical partners and key opinion leaders across the country."