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

Overview

OBJECTIVE: 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. METHODS: This review describes the IDEAL framework and illustrates its application for treatment of uncomplicated type B dissection (uTBD) as an example of this process. RESULTS: 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. CONCLUSIONS: The application of IDEAL to the development and monitoring of technologies standardizes the nomenclature, facilitates evidence-based practice, and enhances the innovation process.