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Calyxo Receives FDA Clearance for Enhanced CVAC System

Wednesday, March 27, 2024

Calyxo, a medical technology company specializing in innovative solutions for kidney stone patients, has announced FDA clearance for its redesigned CVAC System. This system offers a minimally invasive approach to treating kidney stones. Clinical research highlights that post-procedure issues, such as pain, infection, and the need for retreatment, are associated with residual stone fragments in 20%-44% of cases.

The original CVAC Aspiration System, employed in steerable ureteroscopic renal evacuation (SURE), has successfully treated over 1,500 patients in the U.S. Clinical data indicates that vacuum aspiration of stone fragments leads to 97% volumetric stone clearance, reducing the necessity for additional invasive procedures.

Drawing from over two years of practical use, Calyxo has enhanced the CVAC System to optimize the SURE procedure. It now integrates ureteroscopy, laser lithotripsy, irrigation, and aspiration in one device, making it the only comprehensive stone clearance solution worldwide. The redesigned system facilitates effective and efficient kidney stone aspiration by offering direct visualization, dedicated irrigation channels, and a large aspiration lumen.

Through continuous stone dust clearance via passive aspiration during laser lithotripsy and subsequent active vacuum aspiration of residual fragments, the SURE procedure with the new CVAC System achieves highly effective stone clearance. The positive feedback from urologists underscores the potential of this technology, and Calyxo aims to make it more accessible in the coming months.

Kidney stone disease affects approximately 10% of the U.S. population at some point in their lives, as per the American Urological Association, imposing significant healthcare burdens.


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