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FDA clears Rhythmia Mapping System

FDA clears Rhythmia Mapping System

On 24 July, the US Food and Drug Administration (FDA) cleared Boston Scientific’s Rhythmia Mapping System, a next-generation 3D mapping and navigation solution for use in cardiac catheter ablations and other electrophysiology procedures to diagnose or treat cardiac arrhythmias.

According to a company release, 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.

“I believe the Rhythmia Mapping System will become the new gold standard for mapping and navigation,” said Warren Jackman, professor of Medicine, University of Oklahoma Health Sciences Center, USA. “Rhythmia delivers maps of exceptional clarity because it captures thousands versus hundreds of data points. The magic of Rhythmia is continuous mapping. The intelligence built into the system virtually eliminates the need for manual annotation, which is expected to facilitate the diagnosis, treatment and final verification of arrhythmias.”

Boston Scientific is offering the Rhythmia Mapping System with the company’s 64-electrode IntellaMap Orion High Resolution Mapping Catheter, which has also received FDA 510(k) clearance.

The Rhythmia Mapping System received CE mark approval in May 2013.