Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection.
PMID: 28216355 ·
Adam W Beck, Joseph V Lombardi, Dorothy B Abel, J Pablo Morales, Danica Marinac-Dabic, Grace Wang, Ali Azizzadeh, John Kern, Mark Fillinger, Rodney White, Jack L Cronenwett, Richard P Cambria, Society for Vascular Surgery Vascular Quality Initiative TEVAR Surveillance Project Steering Committee
Abstract
United States Food and Drug Administration (FDA)-mandated postapproval studies have long been a mainstay of the continued evaluation of high-risk medical devices after initial marketing approval; however, these studies often present challenges related to patient/physician recruitment and retention. Retrospective single-center studies also do not fully represent the spectrum of real-world performance nor are they likely to have a sufficiently large enough sample size to detect important signals.
Official Source
View on PubMed →Data sourced from PubMed / NCBI. For the full text and most current information, always refer to the official record.