CSA Medical’s trueFreeze Catheter Tech Wins Expanded 510(k) Approval
The FDA awarded 510(k) clearance for an expansion of CSA Medical’s trueFreeze catheter device.
The new approval covers a third spray kit for the trueFreeze system, which allows the user to cut the time of liquid nitrogen spray in half, which shortens overall treatment time. The system is indicated for cryosurgery in dermatological, gynecological and general surgery procedures.
The expansion re-establishes trueFreeze’s approval to treat Barrett’s Esophagus and malignant lesions. The system allows users to deliver liquid nitrogen at far colder temperatures than is needed to destroy cancerous tissues in the esophagus.