Edwards Sapien XT Valve and Delivery Systems Receive CE Mark
March 2, 2010—Edwards Lifesciences (Irvine, CA) announced that it has received CE Mark approval for the Edwards Sapien XT transcatheter aortic heart valve, as well as its NovaFlex transfemoral and Ascendra 2 transapical delivery systems. The company is beginning a limited European launch of the new valve and the 18-F NovaFlex delivery system in the second quarter of 2010.
According to the company, the Sapien XT valve's leaflet design is modeled after their clinically proven aortic tissue valves. Its cobalt-chromium frame provides improved radial strength for enhanced circularity. The Sapien XT is the second commercially available transcatheter valve in the Edwards Sapien product portfolio. In the ...
St. Jude Medical’s Engage Introducer Devices Approved in United States and Europe
March 11, 2010—St. Jude Medical, Inc. (St. Paul, MN) announced US Food and Drug Administration clearance and European CE Mark approval for the Engage and Engage TR introducers for use in diagnostic and interventional cardiac catheterization procedures. The Engage family of introducers incorporates features that offer more control and minimize risks both during access and throughout the procedure, the company stated. According to St. Jude Medical, the Engage introducers are designed to provide femoral access to the vasculature, minimize trauma to the artery, and set the stage...
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SYNTAX Compares CABG and Stenting in Diabetic Patients
March 9, 2010—In the Journal of the American College of Cardiology, Adrian P. Banning, MD, et al published findings from a study designed to compare contemporary surgical revascularization (coronary artery bypass graft surgery [CABG]) versus stenting with the Taxus Express paclitaxel-eluting stents (PES) (Boston Scientific Corporation, Natick, MA) in diabetic and nondiabetic patients with left main and/or three-vessel disease (2010;55:1067–1075). The investigators noted that although the prevalence of diabetes mellitus is increasing, the optimal coronary revascularization strategy in diabetic patients w...
Study Conducted of Long-Term Pulmonary Regurgitation After Balloon Valvuloplasty
March 9, 2010—According to David M. Harrild, MD, et al, balloon pulmonary valvuloplasty relieves pulmonary stenosis (PS) but can cause late pulmonary regurgitation (PR); however, the sequelae of isolated PR are not well understood. Therefore, the investigators conducted a study that sought to examine the prevalence and predictors of PR after balloon dilation for PS and to investigate its impact on ventricular volume and function and exercise tolerance. The findings were published in the Journal of the American College of Cardiology (2010;55:1041–1047). The investigators reported that patients ...