To be fair to @brrrattt, I think he raises some valid points, particularly around commercialisation.
The Micra leadless pacemaker is a good example here. Medtronic announced it in 2015, and received FDA approval in 2016. 8 years later, volumes are still largely non-existent outside of the US (& I can't find US data).
I am bullish on EBR. Having worked in a related industry, I can see the potential for WISE to significantly improve patient outcomes. However, EBR isn't without risks, regardless of FDA approval.
Ann: Positive Results from the SOLVE-CRT Randomised Sub-Study, page-33
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