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3-D mapping and navigation system cleared by FDA

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The FDA has granted 510(k) clearance for a next-generation 3-D mapping and navigation system used in cardiac catheter ablations and other electrophysiology procedures to help diagnose and treat arrhythmia disorders.

In recent years, cardiac mapping has become a standard tool for treating patients with arrhythmia disorders.

The Rhythmia Mapping System (Boston Scientific) allows for automated map creation; with current systems, maps must be created manually. The system also offers improved map density compared with existing systems, according to a company press release.

The system includes a validation map, which can enable cardiologists and electrophysiologists to quickly verify the success of the arrhythmia treatment, according to the release.

The Rhythmia Mapping System received a CE Mark for use in Europe in May 2013.