The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer.
The subject of the FDA warning is Michael Ring, one of the two principal investigators of the CoreValve trial at the Providence Sacred Heart Medical Center site in Spokane, WA.
Click here to read the full story on Forbes. (Updated to include an additional comment from Dr. Ring.)