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Htun N.M.,The Center for Heart Valve Innovation | Webb J.G.,The Center for Heart Valve Innovation
Expert Review of Medical Devices | Year: 2016

Transcatheter aortic valve replacement is a viable alternative to surgical aortic valve replacement in patients with severe aortic stenosis. The SAPIEN 3 is the latest generation of balloon-expandable transcatheter heart valve, designed to address some of the shortcomings of earlier versions of transcatheter heart valves. It has a lower device profile to reduce access-related vascular injury, an improved delivery catheter to facilitate accurate implantation, and incorporates an additional outer sealing cuff to minimize paravalvular leakage. The latest European and North American trials using SAPIEN 3 have documented very low rates of vascular complications and paravalvular regurgitation with rates of stroke and mortality rates lower than anticipated with SAVR in both intermediate and high surgical risk patients. © 2016 Taylor & Francis

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