Is the TAVI Heart Valve Replacement Procedure FDA Approved?3
The TAVI heart valve replacement surgery procedure has not yet been approved by the FDA. The procedure, which stands for transcatheter aortic valve implantation is a minimally invasive valve surgery which treats aortic stenosis.
The TAVI was created in Europe back in 2002 and began being used in clinical practice in 2007. Since then it has been implemented in more than 35 countries and performed in more than 12,000 patients. So far the procedure has proven itself to be a very safe and effective alternative to traditional open heart sugery.
In the United States, however, the minimally invasive valve surgery procedure is still being investigated in several clinical trials. One study, called the PARTNER study reported positive results as of December 2010 leading experts to believe that FDA approval could come as early as late 2011.