FDA approves Rhythmia Mapping System for Arrhythmias
Boston Scientific Corporation has on 24 July 2013 received 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, labour intensive process to create maps, making trade-offs 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.
The Rhythmia Mapping System received CE Mark approval in May of 2013.
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