Preliminary results from MDIC’s Early Feasibility Study (EFS) project were presented on June 16th 2017, at the Transcatheter Valve Therapies (TVT) conference by Chip Hance, Board of Directors Member of MDIC. Slides from the presentation can be found here: Early Feasibility Studies (EFS) in the U.S. with a Focus on Valvular Heart Disease: Updates, Impact and Future Directions.
MDIC’s EFS project is intended to establish a baseline of EFS performance metrics and subsequently develop tools and best practices to improve the efficiency in EFS initiation and conduct. The success of EFS project will support the broad adoption of FDA CDRH EFS program which is envisioned to bring EFS back in the U.S. and provide U.S. patients’ timely access to safe and effective medical device technologies of public health importance first in the world.
Preliminary results identified several improvement opportunities during EFS initiation. In coming months MDIC’s EFS working group will focus on (1) increasing the performance metrics database robustness, and (2) developing tools and best practices to improve EFS efficiency in specific areas.
