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CE Mark for St. Jude's Products

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St. Jude Medical has received CE Mark approval for two of its devices viz. the AMPLATZER Amulet Left Atrial Appendage Occluder and the ViewFlex Xtra Intracardiac Echocardiography (ICE) Catheter. Both the products were unveiled at the 18th annual Boston AF Symposium.  

About AMPLATZER Amulet

The advanced Amulet cardiovascular device from the company’s Cardiovascular and Ablation Technologies Division (CATD) is technically a notch above the original AMPLATZER Cardiac Plug, as it can be used to treat a wider range of appendage anatomies. The percutaneous transcatheter device is intended to seal off left atrial appendage (LAA) in patients ailing from non-valvular atrial fibrillation (AF).

As per the World Health Organization (WHO), strokes occur in approximately 15 million people across the globe every year, rendering it to be one of the leading causes of death and long-term disability. Following the success of the AMPLATZER Cardiac Plug, the Amulet device should further boost structural heart devices sales. However, it has not yet been cleared by the U.S. Food and Drug Administration (FDA). Edwards Lifesciences Corp. (EW - Free Report) also manufactures transcatheter heart valves and currently carries a Zacks Rank #2 (Buy).  

About ViewFlex Xtra

St. Jude’s ViewFlex Xtra ICE Catheter, again from the Cardiovascular and Ablation Technologies Division (earlier AF division), also received the European CE Mark and is already FDA approved. The catheter allows seamless movement during cardiac ablation surgeries, thereby enhancing clinical outcomes.

Along with the ViewMate Z Intracardiac Ultrasound Console, the device provides real-time image guidance and visualization of a patient’s cardiac anatomy and is capable of delivering fast, high-fidelity images, which helps physicians during electrophysiology procedures.

St. Jude forayed into the high-growth ICE market in 2008 with the acquisition of leading electrophysiology products maker EP MedSystems. The medical devices behemoth obtained the ViewFlex ICE catheters and ViewMate II ultrasound imaging system through this acquisition. Medtronics Inc. (MDT - Free Report) is also expanding its foothold in the emerging AF market.

St. Jude will be reporting its fourth-quarter earnings results on Jan 23 and currently carries a Zacks Rank #3. We also look forward to orthopedic major, Stryker Corp.’s (SYK - Free Report) results, releasing tomorrow.   

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