St. Jude Medical (NYSE:STJ) said today that it won 510(k) clearance from the FDA for its EnSite Precision cardiac mapping system and the Advisor FL catheter used with it.
The Ensite cardiac mapping system is designed for use in ablation procedures to visualize and aid in catheter navigation in the heart, providing detailed anatomical models and maps, St. Jude said. The system is designed to aid in diagnosing arrhythmias, guiding therapy and providing expanded procedural options.
“Our new EnSite Precision cardiac mapping system was designed to give the physician a means to precisely navigate within the heart, provide higher density diagnostic data to better inform their diagnosis and allow them to use the tools that make sense for each individual patient and situation,” clinical, medical & scientific affairs VP Dr. Srijoy Mahapatra said in prepared remarks. “The system’s intelligent automation tools enable faster, more accurate high-density maps with greater consistency across cases, which are important factors in addressing the needs of today’s EP labs.”
“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,” added Dr. John Day of Salt Lake City’s Intermountain Medical Center Heart Institute, who is set to perform the 1st U.S. case using the device. “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.”
In October, Little Canada, Minn.-based St. Jude said it’s installed more than 100 EnSite Precision systems in Europe after winning CE Mark approval in January.