FDA panel backs Edwards' Sapien heart valve for lower-risk patients | Heart and Vascular Health | Scoop.it

Take Home Message: Aortic stenosis occurs when the aging aortic valve thickens and narrows.  The only treatment for this has been surgery with valve replacement through an open chest.  Edwards' Sapien heart valve is a catheter approach that allows placement of a replacement valve through the groin artery without surgery, vcalled TAVR or TAVI.  The FDA has previously allowed the use of this device for patients who could not have surgery for valve replacment becuase their risk was too high.  This action, if confirmed, by FDA would allow use of this catheter approach for patients who are high risk, but could have surgery.  The study confirmed that catheter and surgery are equivalent on efficacy and safety.