St. Jude Medical electrophysiology products cleared for use in U.S., Europe

St. Jude Medical Inc. last week announced that it has received FDA clearance of its Safire Ablation Catheter, and FDA clearance and European CE Mark for its Inquiry Optimal PLUS Steerable Diagnostic Catheter. The announcement was made at the Heart Rhythm Society’s 27th Annual Scientific Sessions in Boston.

The Optima PLUS helps physicians map the heart's atria with a 24-electrode catheter that allows physicians to collect more diagnostic data, more quickly when used with St. Jude Medical's EnSite System Version 6 software. Using this 3D imaging technology, the physician will "see" the catheter's position inside the heart. Four electrodes on the 180-degree deflectable shaft display the loop and shaft planes of motion simultaneously, the company said.

In addition to Safire and Optima PLUS, St. Jude Medical is showcasing the EnSite System Version 6 software which received FDA clearance earlier in May. The software is designed to provide highly detailed, 3D cardiac models at the time of an EP procedure. Physicians create the 3D model in small sections that join together automatically, resulting in a cardiac model that shows the openings, ridges and curves in the heart. The models are then used by physicians to collect information about the heart's electrical activity and assist them in diagnosing and treating many arrhythmias, including atrial fibrillation.