(Reuters) – Regulators approved the Edwards Life Sciences Corporation’s heart valve for patients too sick to have open-heart surgery after a clinical trial found that patients receiving the valve experienced 2.5 x more strokes and 8 x as many vascular/ bleeding complications than those who did not receive the implant; but, were more likely to survive one year after surgery (69% compared with 50% of those who received an alternative treatment).
In aortic stenosis, the aortic valve that allows blood to leave the heart does not fully open, decreasing blood flow and potentially preventing it from reaching the brain and the rest of the body.
A bad aortic valve commonly requires open-heart surgery, during which the ribs are sawed open, the heart is stopped and a new valve is sewn in place. This $30,000-worth of cow tissue and polyester supported with a stainless steel mesh frame is giided to the heart via a catheter through the femoral artery in the groin or a small incision between the ribs.
