March 10, 2013 By Steven E. Greer, MD The Healthcare Channel
The main reason that Medicare has limited coverage for the Edwards Lifesciences (EW) Sapien percutaneous aortic valve is the high perioperative complication rate of ischemic strokes, in excess of 9%, as well as femoral artery complications. The newer second generation Sapien XT, with a smaller diameter “French” profile, was hoped to reduce the complications and make the TAVR procedure safer. The newest data on the second-gen Sapien do not seem to support the claims from Marty Leon, financial backer of the valve, that the new valve is safer.
The PARTNER II study was presented at the ACC meeting in San Francisco. Continue reading