FDA Clears St. Jude Medical’s EnSite Precision Cardiac Mapping System

St. Jude Medical Inc., a global medical device company, today 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.
 
When physicians use catheter ablation to treat abnormal heart rhythm, a small area of heart tissue under the tip of the ablation catheter is heated by high-frequency energy, creating a lesion or tiny scar. As a result, this tissue is no longer capable of conducting or sustaining the arrhythmia. Cardiac mapping provides a live view of the heart so physicians can visualize and navigate cardiac anatomy to deliver more precise ablation therapy. The new EnSite Precision cardiac mapping system offers a new dual-technology platform that provides highly detailed anatomical models and maps to enable more efficient treatment of a wide range of arrhythmias—including complex arrhythmias, such as atrial fibrillation or ventricular tachycardia.
 
“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,” said Dr. John Day, medical director of the Intermountain Heart Rhythm Specialists at the Intermountain Medical Center Heart Institute in Salt Lake City, who is set to perform the first case in the United States. “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 EnSite Precision cardiac mapping system is based on the St. Jude Medical EnSite Velocity cardiac mapping system, which is utilized in more than 2,000 electrophysiology labs around the world. The EnSite Precision cardiac mapping system introduces new solutions, including the EnSite AutoMap Module, which will enable the electrophysiologist to more quickly perform morphology matching that identifies the source of the irregular heartbeat using automated cardiac rhythm mapping tools to facilitate treatment. The EnSite AutoMap Module includes the new TurboMap feature, which will allow the physician to build a map of the heart 10 times faster than current systems using recorded data. St. Jude Medical expects this technology to be a new standard for patients experiencing arrhythmias from multiple origins in the heart.
 
“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,” said Dr. Srijoy Mahapatra, vice president of clinical, medical and scientific affairs for St. Jude Medical. “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.”