TCT-4 Transcatheter Tricuspid Valve Repair in Patients With Functional Tricuspid Regurgitation: 2-Year Outcomes From the FORMA US Early Feasibility Study
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DOI: 10.1016/j.jacc.2019.08.026
Abstract: New transcatheter devices are being developed to reduce tricuspid regurgitation (TR) and improve clinical outcomes in selected patients. The FORMA early feasibility study (EFS) was conducted to evaluate the safety and device performance of the… read more here.
Keywords: tricuspid regurgitation; early feasibility; feasibility study; forma early ... See more keywords
TCT-88 6-Month Outcomes of an Early Feasibility Study of the AccuCinch Left Ventricular Repair System in Patients With Heart Failure and Functional Mitral Regurgitation
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DOI: 10.1016/j.jacc.2019.08.129
Abstract: The CorCinch FMR study is a multicenter, nonrandomized, prospective Early Feasibility Study (EFS) designed to evaluate the early safety and performance of the AccuCinch Ventricular Repair (AccuCinch) System and to assess its impact on mitral… read more here.
Keywords: early feasibility; mitral regurgitation; ventricular repair; study ... See more keywords
Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.
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DOI: 10.1016/j.jacc.2020.10.019
Abstract: The development of technology to treat unmet clinical patient needs in the United States has been an important focus for the U.S. Food and Drug Administration and the 2016 Congressional 21st Century Cures Act. In… read more here.
Keywords: early feasibility; program; feasibility studies; united states ... See more keywords
Recommendations for the design and implementation of an Early Feasibility Studies program for medical devices in the European Union
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DOI: 10.1080/17434440.2022.2075729
Abstract: ABSTRACT Introduction Early Feasibility Studies (EFS) are among the pre-market clinical investigations allowed by the International Standard for Clinical investigation of medical devices (MD) for human subjects. The Food and Drug Administration (FDA) introduced an… read more here.
Keywords: medical devices; feasibility studies; program; early feasibility ... See more keywords