Engineering improvements in endovascular devices: design and validation.

Advances in endovascular treatment of vascular disease have focused on basic and translational research of vascular disease and endovascular devices. Clinical trials serve to establish the safety and efficacy of engineering advances that incorporate this research. Recent position statements by the Food and Drug Administration (FDA) emphasize that research into conducting these trials in a timely and cost-effective manner (critical path research) is as important to patient care as the engineering advances themselves. This article reviews the recent FDA documents discussing critical path research, highlighting those topics that the FDA emphasizes. Several directions of translational research in which engineering advances may contribute to enhanced device design and improved patient care are reviewed.