A case study on FDA from my father, a cardiologist: A recent advancement in replacement heart valves reduces mortality rates from 10% in high risk patients (old

A case study on FDA from my father, a cardiologist: A recent advancement in replacement heart valves reduces mortality rates from 10% in high risk patients (old and very unhealthy) to 0.9%, from 5% in medium risk patients to 0.4%. This studies were confirmed through clinical trials run by very well respected doctors. Nevertheless, the FDA still required their own set of trials to confirm the safety of the procedure. This was 5 years ago. The FDA first ran a set of trials, not on standard patients but only those that were deemed "inoperable". They spent a few years working that out and found that the device succeeded, but the approval was only given for patients that were inoperable. Then the FDA covered patients that were high risk, spent a few years and found again that the device was hugely beneficial in mortality rates and the device was approved for high risk patients. We are currently in the waiting for the FDA to approve the device for medium risk patients. In the mean time, my father had a medium risk patient who needed a valve replacement. He could not use the new device, so he sent the man to surgery for a standard valve replacement with 5% mortality risk. The man died on the table, becoming part of the 5%, and my father insists that he would have survived if they had been able to use the new procedure. In Germany there are less regulations, and so they have been using the new technique for 5 years with great success. Because of things like this, you'll commonly see medical procedures in Europe that are 5 years ahead of their counterparts in America, all because the FDA insists on using such plodding methods to verify safety.