CCSVI angioplasty procedure ok to do unless called research
Posted: Sat May 12, 2018 5:18 pm
https://www.medpagetoday.com/special-re ... race/72033
Just one more obstacle preventing research from getting done: it is okay to perform CCSVI angioplasty, it is not okay to research it!The FDA could intervene in the cases of Arata and McGuckin because they were calling their procedures research, over which the agency has jurisdiction. However, the procedure can be done without federal scrutiny if there is no research involved. It is viewed as akin to the "off-label" use of a drug, in that the stent devices were approved for use in arteries, not veins.