Kidney stone clearance is seeing promising advancements with Calyxo’s CVAC System. The company recently announced positive results from its 1-year multi-center ASPIRE study, which was presented at the 41st World Congress of Endourology (WCET) in Seoul, South Korea, in August 2024. According to the study, healthcare consumption (HC) events, including emergency department visits, hospitalizations, and retreatments, were significantly lower after the use of the CVAC System in steerable ureteroscopic renal evacuation (SURE) procedures compared to the standard ureteroscopy (URS). This development is particularly encouraging as the treatment of kidney stones continues to pose a growing challenge in the U.S.
The ASPIRE study results further solidify the CVAC System as a potential game-changer in kidney stone clearance. Dr. Karen L. Stern, a urologist at Mayo Clinic Arizona and the presenter of the study results, highlighted that the data showed significantly lower cumulative incidences of healthcare events after SURE compared to standard URS. She suggested that the CVAC System could have a positive clinical and health economic impact on the treatment of urolithiasis. This comes at a critical time when the prevalence of kidney stones has increased significantly, with reports indicating that the condition now affects 11% of the U.S. population, up from 3.8% in the 1970s, according to the National Kidney Foundation.
Key Findings from the ASPIRE Study
The kidney stone clearance capabilities of the CVAC System were rigorously tested in the ASPIRE study, which enrolled 123 patients in a randomized, prospective trial. The study compared the efficacy and safety of the SURE procedure using the CVAC System with standard URS with basketing. The results were telling: at 12 months, the cumulative incidence of HC events was significantly lower in patients who underwent the SURE procedure. Only two SURE subjects experienced a total of three HC events, compared to 14 events in nine URS patients. Kaplan-Meier analysis further demonstrated that 95.6% of SURE patients remained free of HC events at 12 months, compared to 83.5% of URS patients.
Additionally, Calyxo shared that their CVAC System achieved high rates of kidney stone clearance based on intraoperative visual assessments during laser lithotripsy. The system’s integrated features, such as passive aspiration of stone dust, active aspiration of larger fragments, and direct visualisation, contributed to its high performance and ease of use. The system is the only complete solution that integrates ureteroscopy, laser lithotripsy, irrigation, aspiration, and stone collection. This all-in-one capability enhances the efficiency and effectiveness of kidney stone removal, which was particularly evident in the study’s results.
Calyxo’s Commitment to Improving Kidney Stone Treatments
In addition to the ASPIRE study, Calyxo presented other research at the WCET, including a single-center retrospective chart review of patients who underwent the SURE procedure with the CVAC System from January 2022 through August 2023. The review further supported the system’s kidney stone clearance capabilities, demonstrating high stone-free rates with low morbidity, even in patients with large stone volumes. These findings suggest that the CVAC System is not only a safe and effective treatment option but also a viable alternative to standard URS, with potential to improve patient outcomes and reduce the need for retreatments.
Calyxo remains committed to advancing kidney stone treatments and raising awareness about the benefits of their CVAC System. Joe Catanese, Calyxo’s President and CEO, emphasized that the positive results from the ASPIRE study confirm earlier findings about the safety and efficacy of the CVAC System. With FDA clearance already secured, Calyxo is continuing to work closely with urologists, endourologists, and the broader healthcare community to promote the adoption of this innovative technology. By improving kidney stone clearance and reducing healthcare events, the CVAC System is poised to make a lasting impact on the treatment of kidney stones.
Resource: MED-TECH INNOVATION, August 15, 2024
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