James Kendrick explains:
Tuesday of this week I headed to the hospital for treatment of a blocked carotid artery. …
It turns out the imaging clearly demonstrated that the blockage was only 70-75 percent, and not the 80-90 percent previous imaging had indicated. That turned out to be very significant, as the FDA only allows the stents to be used in patients like me when the blockage is 80 percent or greater. Even though the specialists felt I needed the stent to correct my problem, they were not allowed to put it in. So after three hours of intense work by a great medical team, and even though I was already on the operating table ready for the full treatment, the doctors had to pull out without doing anything other than the angiogram. They faced serious sanctions by the FDA had they continued as planned with the actual correction of my medical problem.
… My doctors’ opinions are still that I need the treatment, but now they must wait and monitor the blockage (for years) until it hits that magic 80 percent that would allow them to treat it properly. Of course if I have a stroke in the future, which the stenting is designed to prevent, then the FDA allows them to perform the treatment in response. They can’t prevent the symptom, but they can respond to it.
Read the whole post: FDA Takes Over in the OR.