Having received the European CE Mark for its Rhythmia Mapping System just last May, Boston Scientific just won FDA clearance for the cardiac mapping and navigation system. The Rhythmia is used in electrophysiology procedures to map out the cardiac tissue and deliver an ablation catheter to the treatment site.
The IntellaMap Orion catheter, also FDA cleared, has 64 electrodes that provide electro-anatomical mapping of the heart.
From the announcement:
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, M.D, professor of Medicine, University of Oklahoma Health Sciences Center. “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.”
Flashback: Boston Scientific Rhythmia Mapping System Cleared in Europe
Press release: Boston Scientific Receives FDA 510(k) Clearance for the Rhythmia™ Mapping System…
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