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TMCNet:  St. Jude Medical receives CE Mark approval for ICE catheter

[January 21, 2013]

St. Jude Medical receives CE Mark approval for ICE catheter

Jan 21, 2013 (Datamonitor via COMTEX) -- St. Jude Medical, Inc., a medical device company, has received European CE Mark approval for its ViewFlex Xtra Intracardiac Echocardiography, or ICE, catheter.

Offering a four-way directional tip, the ViewFlex Xtra ICE Catheter also has the added benefit of auto-lock steering, which allows for single-handed operation of the catheter to minimize repositioning. Paired with the ViewMate Z Intracardiac Ultrasound Console, the integrated products help clinicians better visualize, in real-time, a patient's cardiac anatomy, including internal structure of the heart and blood flow direction, the company said.

The ViewFlex Xtra ICE Catheter received 510(k) clearance from the FDA in 2012. The catheter is inserted in the body through a small incision in the femoral vein (located in the leg) and guided to the heart. The ViewFlex Xtra ICE Catheter offers improved maneuverability to enhance procedural workflow, the company added.

"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, 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." "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 Callaghan, president of the Cardiovascular and Ablation Technologies Division at St. Jude Medical. Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon

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