FDA Clears St. Jude Medical Intracardiac Echo Catheter


July 11, 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 in July 2012. 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 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 (a hole in the heart).

For more information: www.spm.com 

The content of this field is kept private and will not be shown publicly.
Type the characters you see in this picture. (verify using audio)
Type the characters you see in the picture above; if you can't read them, submit the form and a new image will be generated. Not case sensitive.