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Rhythmia Mapping System gets CE mark

Rhythmia Mapping System gets CE mark

On 10 May, Boston Scientific announced that the company 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 procedures to treat cardiac arrhythmias including: atrial flutter, atrial fibrillation and ventricular tachycardia.

According to a company release, the Rhythmia Mapping System is designed to increase speed and improve density of mapping compared to existing systems, potentially offering significant benefit to patients, physicians and health care systems. Boston Scientific announced that it is offering the Rhythmia Mapping System with the company’s 64 electrode IntellaMap Orion Mapping Catheter, which is also CE-marked.

“In a pair of independent clinical studies, we 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,” said Hiroshi Nakagawa, professor of Medicine, director, Clinical Catheter Ablation Program, University of Oklahoma Health Sciences Center, and one of the principle investigators in the studies. “The IntellaMap Orion Catheter has a sophisticated 64 electrode design and unique deployable basket that provided a high degree of maneuverability.”

“We believe the Rhythmia Mapping System can become a leader in EP mapping with unparalleled speed, clarity and simplicity which should enable electrophysiologists to perform procedures with great efficiency and precision,” said Pete Sommerness, general manager, Electrophysiology, Boston Scientific. “Bringing the Rhythmia system to our electrophysiology customers is a major step toward realising our vision to redefine ablation technology.”

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