St. Jude Medical Receives 510(k) Clearance from US FDA for ViewFlex™ ICE Catheter
July 10, 2012 — St. Jude Medical received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the ViewFlex™ Xtra Intracardiac Echocardiography (ICE) Catheter. The catheter technology is designed to be used with the ViewMate™ Z Ultrasound console, a system that provides fast, clear images to help visualize cardiac structures and blood flow within the heart during complex electrophysiology or interventional procedures.
The ViewFlex ICE catheter has an ergonomic handle allowing for single handed, four-way tip deflection and self-locking steering. The new handle helps streamline procedures by providing increased maneuverability with the potential to minimize catheter repositioning.
“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,” said Dr. Dhanunjay Lakkireddy, Professor of Medicine and Director of the Center for Excellence in Atrial Fibrillation and EP Research from the University of Kansas Medical Center in Kansas City, KS who first used the new ViewFlex Xtra ICE Catheter. “The wide range of viewing options and high-quality images allow me to focus more on the patient and less on the catheter.”
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 (RF) ablation to treat irregular heart rhythms and structural heart procedures to close atrial septal defects.