CE Mark For St.Jude’s ViewFlex Xtra ICE Catheter

In short

More publicity for St. Jude Medical, Inc. at last week’s Boston AF congress when it announced that it had gained the CE Mark for its ViewFlex™ Xtra Intracardiac Echocardiography (ICE) Catheter. St.Jude claims this new catheter can be steered and controlled really easily with resultant workflow benefits… see what we do to avoid having the transatlantic debate about how to spell manouevre/maneuver?


With its four-way directional tip, the ViewFlex Xtra ICE Catheter is further enhanced with auto-lock steering, which allows for single-handed operation of the catheter to minimise repositioning. St.Jude says that when paired with its ViewMate™ Z Intracardiac Ultrasound Console, the result is better real-time visualisation of the cardiac anatomy, including internal structure of the heart and blood flow direction.

The high-resolution images and vivid color displays further improve guidance for physicians.

Physician comments

“This technology offers crisp, clear visualization of the patient’s anatomy to help guide us in performing a variety of procedures such as radiofrequency ablation to treat irregular heart rhythms,” said Dhanunjaya Lakkireddy, M.D., cardiologist and professor of internal medicine at the University of Kansas Hospital in Kansas City, Kan. “The ViewFlex ICE Catheter’s easy to use, one-handed operation allows for a more efficient procedure.”

Company comments

“The combination of the ViewFlex Xtra ICE Catheter and ViewMate Z Intracardiac Ultrasound Console in an integrated EP Lab not only yields exceptional images, but more importantly allows physicians to focus on the patient and less on catheter manipulation,” said Frank J. Callaghan, president of the Cardiovascular and Ablation Technologies Division at St. Jude Medical.

US Regulatory status

The ViewFlex Xtra ICE Catheter received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in 2012.

Source: St.Jude Medical, Inc., Business Wire

Image courtesy of Business Wire