510(k) for EP MedSystems' SilverFlex technology:
This article was originally published in Clinica
Executive Summary
EP MedSystems has received US FDA clearance for its new range of silver-coated electrophysiology catheters used in the diagnosis and treatment of cardiac disorders. The Mount Arlington, New Jersey-based company says the advantages of the SilverFlex technology, which was used for coating the catheter tube with a very thin layer of silver, includes flexibility, conductivity and a manufacturing cost savings of up to 50% compared with standard hard metal electrodes. In addition, the technology allows a large number of electrodes to be placed on the catheter.