FDA approves IDE for ACC and STS to study alternative approaches to TAVR

02/13/2013

The FDA has granted an investigational device exemption to the American College of Cardiology and The Society of Thoracic Surgeons to conduct a study assessing alternative access approaches for transcatheter aortic valve replacement. Currently, only the transfemoral approach to TAVR using the Edwards SAPIEN valve and, in some cases, the transapical approach have been approved in the U.S. However, an estimated one out of four patients are not eligible for this approach due to inadequate vessel size, vessel disease and/or other anatomical considerations. "The goal behind the study is to expand the field and extend the benefits of TAVR to broader patient groups," said former ACC President David Holmes, Jr., MD, MACC. "This should be a model for specialty societies, industry and federal regulators aligning efforts to ensure appropriate patient access to a new technology in a cost-effective and evidence-based way." Read the full article on CardioSource.org.

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