Conceptualizing treatment of uncomplicated type B dissection using the IDEAL framework.

Abstract

The objective of this study was to introduce a new framework, called IDEAL (idea, development, exploration, assessment, and long-term study), to guide physicians, investigators, and regulatory agencies through the life cycle of device development and procedural refinement. This review describes the IDEAL framework and illustrates its application for treatment of uncomplicated type B dissection (uTBD) as an example of this process. Components of IDEAL are summarized and applied to devices used to treat uTBD. Treatment of uTBD is currently in the exploration phase, with concurrent assessment and long-term study being facilitated by detailed registries. The application of IDEAL to the development and monitoring of technologies standardizes the nomenclature, facilitates evidence-based practice, and enhances the innovation process.