FDA approves St. Jude Medical's Safire catheter, clears Optima PLUS steerable catheter

By Lisa Kerner

Erie, Pa., May 17 - The Food and Drug Administration approved St. Jude Medical, Inc.'s Safire Ablation Catheter. The company also received FDA clearance and European CE Mark for its Inquiry Optima PLUS Steerable Diagnostic Catheter.

St. Jude Medical made the announcement at the Heart Rhythm Society's 27th Annual Scientific Sessions in Boston, where it will feature the products for the first time, according to a company news release.

The Safire catheter features the ComfortGrip handle and can be integrated into existing radiofrequency generators, giving physicians improved comfort and control during electrophysiology procedures.

St. Jude said the Optima PLUS uses a 24-electrode catheter to help physicians map the heart's atria and quickly collect diagnostic data when used with the company's EnSite System Version 6 software. In addition to Safire and Optima PLUS, St. Jude Medical will showcase a portfolio of catheter-based and surgical ablation products at Heart Rhythm 2006, including the EnSite software and the Agilis NxT Steerable Introducer.

St. Jude Medical is a medical device technology and services company based in St. Paul, Minn.

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