FDA approves TAVI for expanded usage for aortic stenosis
The FDA met in the US on June 14 and reached a landmark decision. The FDA is now recommending a much wider field of use for Transcatheter Aortic Valve Implantation (TAVI). Previously, TAVI had been restricted to those patients who were viewed as being unfit for conventional treatment (ie surgical aortic valve replacement). Now for the first time, TAVI has been placed as a recommendation in those individuals who would be considered high risk for conventional surgical aortic valve implantation.
As severe or critical aortic stenosis represents a high patient risk for non-cardiac surgery, this marks a major turning point in the acceptance of these devices outside of the prior "palliative" or "unfit for surgery" risk profile group.