FDA Clears St. Jude's ViewFlex Xtra ICE Catheter


July 12, 2012—St. Jude Medical, Inc. (St. Paul, MN) received 510(k) clearance from the US Food and Drug Administration for the ViewFlex Xtra intracardiac echocardiography (ICE) catheter. The ViewFlex Xtra ICE catheter is designed to be used with the company's ViewMate Z ultrasound console, which provides images to help visualize cardiac structures and blood flow within the heart during complex electrophysiology or interventional procedures.

According to St. Jude's press release, the images produced by the ViewFlex Xtra ICE catheter and the ViewMate Z ultrasound console help physicians confirm the location of cardiac structures and blood flow during procedures such as radiofrequency ablation and structural heart procedures to close atrial septal defects. The ViewFlex ICE catheter has an ergonomic handle allowing for single-handed, four-way tip deflection and self-locking steering. The new handle provides increased maneuverability, with the potential to minimize catheter repositioning, stated the company.

Dhanunjay Lakkireddy, MD, is the first physician to use the new ViewFlex Xtra ICE catheter. Dr. Lakkireddy is Professor of Medicine and Director of the Center for Excellence in Atrial Fibrillation and Electrophysiology Research from the University of Kansas Medical Center in Kansas City, Kansas. In the company press release, Dr. Lakkireddy commented, “The ViewFlex Xtra catheter offers an advancement to the ViewMate Z ultrasound console through its four-way tip deflection, a feature that allows physicians to more easily obtain desired viewing angles of the cardiac anatomy. The wide range of viewing options and high-quality images allow me to focus more on the patient and less on the catheter.”