The EnSite Precision cardiac mapping system is FDA approved to provide automation, flexibility and precision in cardiac mapping during the treatment of patients with abnormal heart rhythms.- St Jude Medical.

St. Jude Medical announced FDA clearance of its EnSite Precision cardiac mapping system and Advisor FL Circular Mapping Catheter, Sensor Enabled. The new EnSite Precision cardiac mapping system is the latest addition to the company’s electrophysiology portfolio, and is designed to provide automation, flexibility and precision in cardiac mapping during the treatment of patients with abnormal heart rhythms (cardiac arrhythmias). Prominent European electrophysiology labs and hospitals have embraced this next-generation platform, which has been used in thousands of cases in Europe since receiving CE Mark in January 2016.

The EnSite Precision cardiac mapping system is flexible and enhances workflow efficiency by allowing physicians to map heart chambers with any electrophysiology catheter and customize procedures to address the circumstances of each case. The St. Jude Medical EnSite Precision cardiac mapping system and the company’s sensor enabled tools also allow catheter navigation to occur with minimal fluoroscopy, thus reducing potential for risks associated with excessive radiation exposure. The launch of the EnSite Precision cardiac mapping system includes other portfolio advancements that include new surface electrodes (patches) and sensor-enabled mapping catheters. These new tools along with the TactiCath Quartz contact force ablation catheter are part of the company’s comprehensive EP portfolio to help optimize clinical outcomes for treating arrhythmias.

Comment: CE Mark was granted in January 2016.