Boston Scientific won the European CE Mark for its Rhythmia Mapping System, a product developed by Burlington, MA-based Rhythmia and purchased by Boston Sci last year. The mapping system takes advantage of the IntellaMap Orion catheter that features 64 electrodes to provide fast and detailed electro-anatomical mapping of the heart.
Rhythmia is still an investigational device in the U.S. and not approved for clinical use by the FDA.
“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, M.D., PhD, 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.”
Mapping and navigation systems have become a standard tool for physicians performing catheter ablations, and current systems demand tradeoffs between accuracy and speed. A more accurate, high resolution image may improve a physician’s ability to select the appropriate site to ablate, improving procedural efficacy. Similarly, increasing the speed at which a mapping system can provide a high resolution map may significantly reduce procedure time. 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.
Press release: Boston Scientific Receives CE Mark Approval For The Rhythmia™ Mapping System…
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