Calcula Technologies Announces Successful Completion of Initial Clinical Cases Following 510(k) Clearance of Their Peralta Stone Removal Catheter
SAN FRANCISCO: Calcula Technologies, a company focused on improving kidney and ureteral stone treatment, announced the successful completion of their initial clinical cases following the recent FDA 510(k) clearance of the Peralta Stone Removal Catheter.
The Peralta Catheter was designed to overcome limitations in current stone removal technologies and enable the safe and rapid removal of stones. The catheter works by enveloping stones and fragments in a protective balloon sleeve. The balloon sleeve provides a low-friction barrier between the stone and ureteral wall, substantially reducing removal force while protecting the ureteral wall from the edges of the stone. The balloon can also be inflated to provide temporary dilation to facilitate stone passage. The catheter was developed to be used in a range of clinical settings.
The ureteral and kidney stone cases were successfully completed at three facilities in the San Francisco Bay Area as part of a pilot commercial launch.
CEO Buzz Bonneau commented “The Peralta Stone Removal Catheter is a promising new tool in the treatment of ureteral stones. We are excited about the clinical outcomes in our initial clinical cases, particularly for whole ureteral stones and larger fragments. Calcula plans to expand its pilot program to additional clinical sites in the coming months based on the success and physician excitement around our initial cases.”