St. Jude Medical has secured approval from the US Food and Drug Administration (FDA) for its EnSite Precision cardiac mapping system.
The company also received the FDA approval for Advisor FL circular mapping catheter, Sensor Enabled.
Part of the electrophysiology portfolio, the EnSite Precision cardiac mapping system will offer automation, flexibility and precision in cardiac mapping during the treatment of patients with abnormal heart rhythms (cardiac arrhythmias).
The EnSite Precision system enables physicians to map heart chambers with any electrophysiology catheter and customize procedures as per the requirement of each case.
It features new dual-technology platform, which provides detailed anatomical models and maps that help to treat a range of arrhythmias such as atrial fibrillation or ventricular tachycardia.
Based on EnSite Velocity cardiac mapping system, the EnSite Precision system also uses EnSite AutoMap module, which helps to effectively perform morphology matching that identifies the source of the irregular heartbeat using automated cardiac rhythm mapping tools to facilitate treatment.
The system’s new TurboMap feature will enable the physician to build a map of the heart rapidly by using recorded data.
The cardiac mapping system, along with firm’s sensor enabled tools, will allow catheter navigation to occur with minimal fluoroscopy, helping to reduce potential risks associated with excessive radiation exposure.
St. Jude Medical clinical, medical and scientific affairs vice president Srijoy Mahapatra said: “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.
Image: St. Jude Medical’s EnSite precision cardiac mapping system. Photo: courtesy of St. Jude Medical, Inc.