Andy, Techxen, Anyone, is it possible with the European approvals in place and evidence such as this, that FDA will not require a trial for removal of blood thinners? This person had the double whammy of having an infected prosthetic valve. Way more dangerous than a bypass with someone already on thinners as a successful surgery is not the end of the story. Months of antibiotics are needed after this operation. This adds the possibility of sepsis/cytokine storm. Frustrated by the FDA delay. Sorry all. It seems like the evidence is there. Git 'er done!