Boston Scientific Receives FDA 510(k) Clearance for the Rhythmia Mapping System

Boston Scientific Corporation

has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rhythmia™ Mapping System, a next-generation 3D mapping and navigation solution for use in cardiac catheter ablations and other electrophysiology (EP) procedures to diagnose or treat a variety of conditions in which the heart beats abnormally.  Cardiac mapping has become a standard tool for the diagnosis and treatment of arrhythmias. Current mapping systems require a manual, labor intensive process to create maps, making tradeoffs between accuracy and speed.  Current systems also offer limited indication of therapy success. The Rhythmia Mapping System is designed to intelligently automate map creation, increasing the speed and improving the density of mapping compared to existing systems.  The system also features vMap™, a validation map, which is designed to enable electrophysiologists, for the first time, to rapidly confirm the endpoints of the ablation treatment.