Maximus,
There's an FDA meeting on January 11 regarding the Linx. That meeting may shed some light as to how soon we might see FDA approval in the U.S.
Also they are supposed to publish background material two days prior to the meeting, so perhaps we will see the results from the U.S. clinical trial regarding the Linx to show what the success rate and frequency of side effects has been so far.
Here's a link to the meeting notice:
www.fda.gov/AdvisoryCommittees/Calendar/ucm280285.htm