FDA perspective on clinical trial design for femoropopliteal stent correction of peripheral vascular insufficiency cardiovascular devices

The article by Rocha-Singh et al. [1].on behalf of the VIVA Physicians Incorporate (VPI) in this issue of the Catheterization and Cardiac Interventions addresses the challenge to designing clinical trials for devices intended to correct femoropopliteal arterial insufficiency.As discussed in this article, the polymorphic pathology of this disease process accounts for a broad spectrum of clinical presentations that confounds the ability to design and execute a conventional controlled clinical trial.The authors suggest that this problem may be addressed by devising performance goals based on historical data that will allow study of a particular technological advance, use of mechanical stenting in treatment of peripheral arterial disease (PAD), by means of logistically feasible observational studies.This editorial reviews aspects of this proposal from the perspective of the authors in terms of their understanding of the statutory obligations of the Food and Drug Administration (FDA) to regulate the marketing of cardiovascular implants based on valid scientific evidence.