Calyxo
Calyxo, a medical device company developing solutions for patients with kidney stones, has announced positive new study results for its CVAC System in kidney stone clearance.
The new data shows that healthcare consumption (HC) events including emergency department (ED) visits, hospitalisation and retreatment were ‘significantly’ lower after steerable ureteroscopic renal evacuation (SURE) with the CVAC System compared to ureteroscopy (URS) according to the company.
The 1-year multi-centre ASPIRE study results, along with other key CVAC System data, were presented at the 41st World Congress of Endourology (WCET) in Seoul, South Korea, in August 2024.
“The ASPIRE 1-year data shows significantly lower cumulative incidence of HC events after SURE compared to standard URS,” said Dr. Karen L. Stern, urologist at the Mayo Clinic Arizona and presenter of the study results. “This new data suggests that the new CVAC System may have the potential for a positive clinical and health economic impact in the treatment of urolithiasis.”
Calyxo says the treatment of kidney stones in the United States continues to be a growing challenge, with its prevalence increasing from 3.8% in the late 1970s to 11% in 2021, according to data from the National Kidney Foundation. Other studies have reported that an estimated 23% of patients needed retreatment during the first year following URS.
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The SURE procedure is exclusively performed with the CVAC System and is the “only complete stone clearance solution that enables effective and efficient kidney stone removal” according to the company. Calyxo says that it is an all-in-one system that integrates ureteroscopy, laser lithotripsy, irrigation, aspiration, and stone collection.
The multi-centre ASPIRE study is a prospective, randomised study comparing the safety and efficacy of the SURE approach with the CVAC System vs standard URS with basketing in 123 patients.
Calyxo says that at 12 months, the study showed that HC events are ‘significantly’ lower after SURE compared to URS.
The results showed:
- 101 out of 123 randomised subjects qualified for the efficacy analysis (SURE 46 vs URS 55)
- The 12-month subject retention was 95%
- At 1-year, the cumulative incidence of HC events was ‘significantly’ lower for SURE versus URS (3 HC events in 2 subjects vs 14 HC events in 9 subjects, p=0.015)
- Kaplan-Meier analysis demonstrated that by 12 months, 95.6% of SURE subjects were free of HC events versus 83.5% for URS subjects
Calyxo says that additional data presented at WCET showed that the system achieved high stone clearance per intraoperative visual assessment with improved ease of use. Top performance attributes included passive aspiration of dust during laser lithotripsy, active aspiration of larger fragments, direct visualisation, and all-in-one capability of the system.
Other research included a single centre retrospective chart review of all patients who underwent SURE from January 2022 through August 2023. The company says this showed that SURE with the CVAC System is a ‘safe and effective’ treatment option for patients undergoing URS with high stone free rate comparable to URS alone. The company says this research was associated with low morbidity even with treating large volume stone disease.
“These important results presented during WCET further advance and confirm earlier data showing that the SURE approach with the CVAC System is safe and provides better stone clearance compared to standard URS,” said Joe Catanese, Calyxo’s President and CEO. “We are continuing to work with urologists, endourologists and the healthcare community to raise awareness about our new FDA-cleared CVAC System and how it can help improve outcomes for patients with kidney stones.”
