New CVAC System From Calyxo Obtains FDA Clearance

Medical device manufacturer Calyxo, Inc., received US Food and Drug Administration clearance for its new, redesigned CVAC System. This system enables a minimally invasive approach to kidney stone treatment. More than 50 patients have already undergone procedures using the new system.

The original CVAC Aspiration System has been used in steerable ureteroscopic renal evacuation (SURE) to treat more than 1500 patients in the United States. The device performs vacuum aspiration of stone fragments to improve clinical outcomes.

The new system, also used with SURE, is a complete stone clearance solution that integrates ureteroscopy, laser lithotripsy, irrigation, and aspiration in one device. It combines direct visualization with dedicated irrigation channels and a large aspiration lumen to aspirate kidney stones efficiently and effectively.

“The most commonly used kidney stone treatments today do not reliably remove all of the stone fragments and dust,” said Brian Eisner, MD, director of the kidney stone program at Massachusetts General Hospital and founding clinical advisor of 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.”