The Society of Thoracic Surgeons and the American College of Cardiology have received investigational device exemption approval to conduct a clinical study evaluating broader use of transcatheter aortic valve replacement. This marks the first time medical societies have pursued an IDE, according to SCAI trustee Dr. Ralph Brindis. "The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients," he said. The groups are now pursuing FDA approval for two more studies in hopes of expanding the uses of transcatheter aortic valve replacement.
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