here is the link where it mentions that they got CE for (It is uniquely packaged with the valve fully pre-attached to the delivery system, which facilitates simple and rapid device preparation).
Some more information about their main products:
Edwards.117.007767.pdf
https://www.edwards.com/devices/heart-valves/transcatheter-Sapien-3-Ultra
some general news:
Valve-in-valve TAVR proves successful in the long-term
Endocarditis After TAVR
CHOICE: Outcomes similar between two TAVR systems at 5 years
here is the link where it mentions that they got CE for (It is...
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