US-based kidney care company Calyxo has announced the results of a multicenter study finding that its central venous access catheter (CVAC) device for the treatment of kidney stones drastically cut down on the rate of patients returning to hospital.
Presented as part of the 41st World Congress of Endourology and Uro-Technology (WCET) in Seoul, South Korea, the ASPIRE study saw 95% of participants who used the company’s CVAC device receiving steerable ureteroscopic renal evacuation (SURE) saw no adverse events following treatment. The device and SURE procedure were measured against patients receiving a standard ureteroscopy treatment.
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According to Calyxo, 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. The ASPIRE study saw 123 subjects followed for 12 months after treatment, with only two patients experiencing an adverse event.
Karen Stern, urologist at the Mayo Clinic Arizona and presenter of the study results at the Seoul conference, said: “The ASPIRE 1-year data shows significantly lower cumulative incidence of healthcare events after SURE compared to standard URS. his 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.”
Research by the US National Kidney Foundation found that the prevalence of kidney stones in adults has grown from 8.8% in the late 2000s to up to 11% of Americans affected by 2021. Additionally, an estimated 23% of patients needed retreatment during the first year following standard ureteroscopy treatment.
Calyxo CEO Joe Catanese said: “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.
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By GlobalData“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.”
The announcement follows after Calyxo’s CVAC system was granted market clearance by the US Food and Drug Administration earlier this year. Elsewhere in the kidney care market, medical device giant Baxter has signed over its kidney care arm to investment company Carlyle for $3.5bn.
