FDA clears St. Jude's latest cardiac mapping device

The EnSite Precision system features some upgrades over its predecessor that help physicians perform catheter ablation procedures more quickly and accurately.

St. Jude Medical picked up an FDA nod for its new cardiac mapping system and a sensor-enabled catheter, which guides clinicians treating patients with arrhythmias so they can perform procedures more quickly and more accurately.

Abnormal heart rhythms can be treated with catheter ablation, which creates a lesion in a small region of heart tissue, rendering that area unable to conduct or sustain the arrhythmia. Cardiac mapping guides the physician, providing a live view of the heart as he or she performs the procedure. In addition to an ablation catheter, diagnostic catheters are used in the treatment.They record electrical data from the heart and display it in a map, which is then used to assess the arrhythmia.

The EnSite Precision cardiac mapping system and sensor-enabled Advisor FL Circular Mapping Catheter, which earned a CE mark in January, is based on St. Jude’s EnSite Velocity mapping system. It displays “highly detailed anatomical models and maps” that allow for more efficient treatment of various arrhythmias, according to a statement.

CONFERENCE

AI Innovations for Life Science and Healthcare Summit East

Join the expert speaking faculty of over 30 life science, healthcare, and tech professionals on June 13–14, 2019, in Philadelphia, as we elevate clinical trial operations, healthcare outcomes, and supply chain implementation through AI. Use Discount Code 796819FIERCE to save 15% off the standard registration rate.

“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, which will perform the first procedure with the new device. Among the EnSite’s upgrades is a feature that enables physicians to create a map of the heart 10 times faster than existing systems do.

“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, in the statement. “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.”

In October, Abbott and St. Jude disclosed that they would divest parts of their vascular closure and electrophysiology businesses to Terumo ahead of their $25 billion merger.

Read more on

Suggested Articles

Boston Scientific received approval for its heart valve on the eve of its first-quarter report and after the FDA halted its sales of surgical mesh.

FierceBiotech's Amirah Al Idrus tried out B-Temia's Keeogo, a "dermoskeletic" device that combines sensors, algorithms and motors to help…

The FDA has proposed to reclassify surgical staplers as higher-risk medical devices following an increasing number of safety reports in recent years.