Calyxo Gets FDA OK for Redesigned CVAC System

Calyxo has received U.S. Food and Drug Administration (FDA) clearance for its redesigned CVAC system, which allows a minimally invasive approach for treating kidney stones.
 
The company said over 50 procedures have taken place, with 12 urologists using the new CVAC system. Calyxo also said the procedures yielded strong outcomes and consistently positive feedback from physicians.
 
The original CVAC aspiration system has used steerable ureteroscopic renal evacuation (SURE) to successfully treat over 1,500 U.S. patients, in order to show vacuum aspiration of kidney stone fragments boosts outcomes. Clinical study data has shown 97% volumetric stone clearance and a high chance of not needing a secondary or more invasive procedure.
 
Calyxo modified the device based on over two years of real-world use. The reimagined CVAC system further enhances the SURE procedure—it’s purportedly the only complete stone clearance device that merges ureteroscopy, laser lithotripsy, irrigation, and aspiration in a single device.
 
The new CVAC system allows effective, efficient kidney stone aspiration by incorporating direct visualization with dedicated irrigation channels and a large aspiration lumen.
 
“Calyxo was founded to dramatically improve care for patients suffering from kidney stones,” said Calyxo’s president and CEO Joe Catanese, Ph.D. “We are excited to introduce the first complete stone clearance solution, which we believe will revolutionize 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 most commonly used kidney stone treatments today do not reliably remove all of the stone fragments and dust,” added endourologist Brian Eisner, MD, Director of Kidney Stone Program, Massachusetts General Hospital (MGH) and founding clinical advisor to Calyxo. “We know that vacuum aspiration of stone fragments during ureteroscopy with laser lithotripsy under direct visualization provides unique advantages to enable better stone clearance for our patients who, in some cases, will experience a less invasive procedure with a decreased need for additional treatments.” Dr. Eisner is a pioneer in the field of kidney stone care and Calyxo has licensed technology from MGH.
 
Last month, Calyxo shared data from its “Steerable Ureteroscopic Renal Evacuation (SURE) for Large Renal Stones: A Multi-Institutional Center Study” trial.