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.
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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.
) 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
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
) 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,
) results, releasing tomorrow.