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FDA clears redesigned kidney stone treatment tech from Calyxo

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Oct 14, 2024

FDA clears redesigned kidney stone treatment tech from Calyxo

March 26, 2024 By Sean Whooley Pleasanton, California–based Calyxo’s CVAC system uses irrigation and aspiration to remove kidney stones. The design aims to minimize residual stone burden. CVAC’s

March 26, 2024 By Sean Whooley

Pleasanton, California–based Calyxo’s CVAC system uses irrigation and aspiration to remove kidney stones. The design aims to minimize residual stone burden.

CVAC’s original design, which used steerable ureteroscopic renal evacuation (SURE) already successfully treated more than 1,500 patients in the U.S. In those treatments, in demonstrated improved clinical outcomes, with 97% volumentric stone clearance, plus a high likelihood of avoiding a secondary or more invasive procedure.

Twelve urologists already used Calyxo’s redesigned CVAC system in more than 50 procedures. The company reported strong patient outcomes and positive physician feedback.

The redesigned system follows more than two years of real-world use. Calyxo reimagined it as the only stone clearance solution integrating ureteroscopy, laser lithotripsy, irrigation and aspiration in one device. The company said incorporating direct visualization with dedicated irrigation channels and a large aspiration lumen enables effective and efficient kidney stone aspiration.

Calyxo President and CEO Joe Catanese said the company hopes to “revolutionize” the treatment of kidney stones.

“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,” Catanese said. “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.”

Filed Under: 510(k), Food & Drug Administration (FDA), Regulatory/Compliance, Urology Tagged With: Calyxo