X Technologies Inc has filed its third and final module of its pre-market approval (PMA) application with the U.S. Food and Drug Administration (FDA) for its FX miniRAIL RX PCI Catheter. This final module contains the results from a 263 patient multi-center trial designed to investigate the safety and effectiveness of this novel Focused Force Angioplasty sy 
stem.
The FX miniRAIL is a low profile, 6F compatible system that integrates two flexible stainless steel wires adjacent to the dilatation balloon. These wires focus the balloon's dilatation force to create two longitudinal expansion planes in the coronary plaque and stabilize the balloon across the target lesion. The device has a short, 12mm guide wire lumen that facilitates rapid, single operator exchanges.