CE Mark for Two St. Jude Devices

Published date : 23 January 2013
Article date : 23 January 2013


Zacks Equity Research reports that St. Jude Medical has received CE Mark approval for the Amplatzer Amulet Left Atrial Appendage Occluder and the ViewFlex Xtra Intracardiac Echocardiography Catheter. The devices were first unveiled at the 18th annual Boston AF Symposium. 

According to he manufacturer, the advanced Amulet cardiovascular device is further advanced than the original Amplatzer Cardiac Plug because it can be used to treat a wider range of appendage anatomies. The percutaneous transcatheter device is intended to seal off left atrial appendage in patients ailing from non-valvular atrial fibrillation. The device has not yet been cleared by the FDA.

The ViewFlex Xtra ICE Catheter has received the CE Mark and it is already FDA approved. The catheter allows seamless movement during cardiac ablation surgeries with the aim of enhancing clinical outcomes. Along with the ViewMate Z Intracardiac Ultrasound Console, the device provides real-time image guidance and visualisation of a patient’s cardiac anatomy. It is capable of delivering fast, high-fidelity images.

Source: Zacks Equity Research, 22 January 2013.

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