Clinical Data Show Superior Kidney Stone Clearance Rates for Calyxo’s CVAC System

Calyxo Inc. is releasing positive study results for its kidney stone removal technology, lauding evidence showing its steerable ureteroscopic renal evacuation (SURE) system is better at removing stones than standard treatment.

The prospective, randomized, multi-center ASPIRE trial examined the safety and efficacy of Calyxo’s CVAC System vs. ureteroscopy (URS) with basketing. The ASPIRE study’s 30-day results indicate SURE is statistically superior to standard ureteroscopy (URS) at clearing stones and leaves significantly lower residual stone volume. Unlike standard URS, the CVAC System achieved these results independent of baseline stone burden. Safety was comparable between groups. An analysis of one-year data also showed a dramatically lower number of emergency department visits, hospitalization, and/or retreatment events for SURE patients compared to URS patients.
 
“Based on our study results, the SURE procedure was determined to be a safe kidney stone treatment that delivers consistently higher stone clearance and lower residual stone volume when compared with URS,” reported urologist Thomas Chi, M.D., of the University of California, San Francisco. “This efficacy and safety data, coupled with patient outcomes through the first year of follow-up indicates significant promise for SURE procedure using the CVAC System as a potential new gold standard of treatment.” 
 
Calyxo recently introduced the redesigned CVAC System, an all-in-one, complete stone clearance device integrating ureteroscopy, laser lithotripsy, irrigation, and aspiration. In the early user evaluation, 47 urologists performed 152 cases with the CVAC System and reported a 99% median stone clearance, assessed visually at the end of the procedure. Further, the performance of the CVAC System was judged to be “better than a ureteroscope” in 98% of cases. Finally, in the 70 patients expected to require more than one ureteroscopic procedure, physicians believed that CVAC helped avoid the second procedure 77% of the time. These results were collected through physician surveys after the procedure; clinical studies are planned to confirm these findings.
 
“Urologist feedback on the new CVAC System and the associated clinical evidence was overwhelmingly positive,” Calyxo President/CEO Joe Catanese, Ph.D., said. “We look forward to making the technology more widely available to help more patients in the coming months.”
 
Approximately 10% of people in the United States will have a kidney stone at some point in their lives, according to the American Urological Association. Kidney stone disease is a painful condition that brings with it significant healthcare costs (Current Urology Reports estimates $4.1 billion in annual direct treatment costs by 2030).
 
Calyxo, Inc. is a medical device company focused on improving kidney stone treatment and care by delivering solutions that enable urologists to safely, effectively and efficiently achieve positive clinical outcomes. The company is based in Pleasanton, Calif.