Abstract
The use of fenestrated endovascular devices for repair of complex aortic aneurysms has increased to nearly 5,000 implantations annually among Medicare patients in the United States in recent years. Given that nearly all aspects of treatment for minimally invasive aortic intervention rely on medical devices to better care for patients with vascular disease, clearly understanding how new and innovative technology evolves over the life cycle of a medical device is an essential skill set for cardiovascular physicians. Despite the need for this understanding, there is no standard framework upon which cardiovascular physicians, regulators, and patients can rely on to better understand the evolution of evidence from product inception through adoption and long-term effectiveness evaluation. As the aforementioned devices are increasingly and broadly used, the need for a formal framework for regulation and device approval has emerged. The goal of this review is to describe the Idea, Development, Exploration, Assessment, Long-term Study Framework for Devices (IDEAL-D). This framework is a model developed recently by an international panel of experts dedicated to better understanding the data steps necessary to bring a device from idea to routine practice and further to marketing, approval, and monitoring. In this review, we use the example of fenestrated endovascular aortic devices to illustrate the IDEAL-D framework, how it can help cardiovascular physicians improve their understanding of new technology, and the evidence which surrounds it from inception to long-term use.