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FDA clears cardiac mapping system used during catheter ablation
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St. Jude Medical announced the FDA has cleared a new cardiac mapping system and mapping catheter for use during catheter ablation for treatment of arrhythmias.
The new cardiac mapping system (EnSite Precision) provides physicians with detailed anatomical models and maps, enabling more efficient treatment of complex arrhythmias, including atrial fibrillation and ventricular tachycardia, the company stated in a press release.
Also cleared was a sensor-enabled circular mapping catheter (Advisor FL), according to the release.
“The new EnSite Precision cardiac mapping system allows more mapping data to be collected in a shorter amount of time compared to today’s technologies,” John D. Day, MD, FHRS, medical director of the Intermountain Heart Rhythm Specialists at the Intermountain Medical Center Heart Institute, Salt Lake City, said in the release. “We look forward to implementing the EnSite Precision cardiac mapping system and the new St. Jude Medical Sensor Enabled tools to help guide therapy and provide expanded procedural options to tailor care for patients in simple to complex ablation scenarios, as well as deliver a new level of accuracy and speed in our procedures.”
The mapping system includes a module (EnSite AutoMap Module) enabling quick identification of the source of the arrhythmia and a feature (TurboMap) which allows physicians to build a map of the heart 10 times faster than with existing systems, according to the release.
The new products enable catheter navigation with minimal fluoroscopy, reducing risk for adverse events associated with excessive radiation exposure, the company stated in the release.
Disclosure: Day reports no relevant financial disclosures.