Calyxo Launches Reverse Deflection CVAC System, Shares Positive Data

Calyxo, a company advancing solutions for kidney stone treatment, has launched Reverse Deflection on its second-generation CVAC system.

The enhancement lets endourologists perform the SURE procedure using their preferred steering mode. Calyxo also shared that 15 presentations showing the safety, efficacy, and benefits of SURE using CVAC were featured at WCET 2025. These included randomized controlled, prospective, retrospective, real-world evidence, and ex vivo studies, with five newly reported data sets.

Reverse Deflection CVAC system

The second-gen CVAC system launched last year first featured Standard Deflection—the device tip bends upward when the steering level is moved up. Some endourologists mainly use Reverse Deflection system, which bend the tip downward with the steering lever’s upward motion.

Switching configurations can increase cognitive load on the physician. Calyxo acted quickly to introduce a Reverse Deflection option for an easier, more intuitive navigation experience.

“This offering reflects Calyxo’s agility and excellence in responding to the needs of endourologists, said Margaret Knoedler, M.D., Assistant Professor at the University of Wisconsin School of Medicine and Public Health, Department of Urology, who trialed the device during early market evaluation. “By delivering a reverse deflection option, they’ve empowered more physicians like myself, who prefer this mode, to access the benefits of the CVAC System with greater control and familiarity.”

New clinical evidence for SURE with the CVAC system

Results from the study “Steerable Ureteroscopic Renal Evacuation Reduces the Risk of Healthcare Consumption Events at 2 Years Compared to Standard Ureteroscopy (URS)” were shared at WCET. The presentation reported two-year results on the aspiration of kidney stones.

Of the 101 subjects, there were significantly fewer healthcare consumption events (HCEs) in the SURE cohort compared to the URS cohort—a 73% reduction in HCE risk with SURE compared with URS.

Findings from the company’s CLEARANCE study were also presented, a prospective evaluation of the second-gen CVAC system in 30 patients across ten surgeons. Average stone volume prior to SURE was 703.6 mm³, with a mean density of 1,203 Hounsfield units (HU). The study showed high stone clearance rates (93.8% at POD 1, 96.2% at POD 30) and low RSV (36.0 mm³ at POD 1 to 14.1 mm³ at POD 30), regardless of initial stone burden and more demanding stone density.

Data from a large real-world retrospective study and the first prospective comparison of SURE with CVAC and Flexible and Navigable Sheaths (FANS). The study showed CVAC outperformed FANS in an unmatched cohort, where the SURE arm has a baseline stone volume three times that of FANS. Further studies demonstrated its efficacy in high-burden and complex cases, the company said.

“In just over 15 months since launching the second-generation device, Calyxo has accelerated innovation in the kidney stone market—driving both product iteration and generating pathbreaking clinical evidence,” said Joe Catanese, CEO, Calyxo. “With the introduction of our latest enhancement featuring Reverse Deflection, we believe we’re unlocking access to a better standard of care for thousands of kidney stone patients. We’re also incredibly encouraged by the growing body of research on the CVAC System emerging from leading institutions nationwide, which proves the consistency of outcomes across studies. The two-year ASPIRE outcomes are particularly compelling, given their impact on the overall patient care ecosystem. Our presence at WCET this year is a powerful reflection of the technology’s potential—not just for today’s patients, but for the future of urologic innovation.”