The US Food and Drug Administration (FDA) has approved Calyxo’s redesigned CVAC System, a medical device aimed at enhancing the treatment of kidney stones through a minimally invasive approach.

This new system has already been used in more than 50 procedures, receiving positive feedback from both patients and physicians.

The utilisation of the original CVAC Aspiration System in steerable ureteroscopic renal evacuation (SURE) has proven effective in treating over 1,500 patients in the US.

This method has showcased notable improvements in clinical outcomes, boasting a volumetric stone clearance rate of 97%.

Clinical study data from treated patients indicates a high success rate in avoiding secondary or more invasive procedures.

The redesigned system is the result of two years of real-world application and feedback. It is claimed to be a unique complete stone clearance solution that integrates ureteroscopy, laser lithotripsy, irrigation, and aspiration.

Calyxo president and CEO Joe Catanese said: “We are excited to introduce the first complete stone clearance solution, which we believe will revolutionise how kidney stones are treated.

“By enabling the physician to continuously clear stone dust through passive aspiration during laser lithotripsy and then remove residual fragments through active vacuum aspiration, the SURE procedure with our new CVAC system leads to highly effective stone clearance.

“We are gratified with the overwhelmingly positive feedback from urologists thus far and we are looking forward to making the technology more widely available in the coming months.”

The system is said to offer direct visualisation, dedicated irrigation channels, and a large aspiration lumen for the effective and efficient removal of kidney stones.

Last year, Calyxo closed $50m in a Series D financing round to support a broad launch of CVAC kidney stone treatments.

The round was led by Avidity Partners with significant participation from existing investors Questa Capital and CRG.