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Boston Scientific receives CE Mark approval for next-generation 3D mapping system

Boston Scientific has received CE Mark approval 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 treat abnormal heart beats.

Offered with the company’s 64 electrode IntellaMap Orion Mapping Catheter, the Rhythmia Mapping System is designed to increase speed and density of mapping compared to existing systems, potentially offering significant benefit to patients, physicians and health care systems.

University of Oklahoma Health Sciences Center Clinical Catheter Ablation Program director and one of the principle investigators of the studies Hiroshi Nakagawa said independent clinical studies have repeatedly showed that the Rhythmia Mapping System can rapidly generate and display high density electro-anatomical maps that allowed clinicians to effectively diagnose and treat even the most complex patients.

"The IntellaMap Orion Catheter has a sophisticated 64 electrode design and unique deployable basket that provided a high degree of maneuverability," Nakagawa added.

In the US, the Rhythmia Mapping System is an investigational device and not available for sale.