FDA clears St. Jude's intracardiac echo catheter
St. Jude Medical received 510(k) clearance from the 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 images to visualize cardiac structures and blood flow within the heart during electrophysiology or interventional procedures, the St. Paul, Minn.-based company said in a release. The ViewFlex ICE catheter has a new handle, allowing for single-handed, four-way tip deflection and self-locking steering.
The catheter technology is designed to be used with the ViewMate Z Ultrasound console, a system that provides images to visualize cardiac structures and blood flow within the heart during electrophysiology or interventional procedures, the St. Paul, Minn.-based company said in a release. The ViewFlex ICE catheter has a new handle, allowing for single-handed, four-way tip deflection and self-locking steering.